nail surgery guidance - salford royal nhs foundation trust

Nail Surgery Guidance

Reference Number TWCG28(14) Version 5 Issue Date: 30/01/2020 of 30 It is your responsibil ity to check on the intranet that this printed copy is the latest version


Lead Author: Anne-Marie Jones Specialist Podiatrist

Additional author(s) Vikki Pestridge Operational Lead Lindsay Jones Vascular Specialist

Podiatrist Louise Berry Advanced Podiatrist

Division/ Department:: Podiatry

Applies to: (Please delete) Salford Royal Care Organisation

Approving Committee Salford Royal Podiatry Department

Date approved: 06/12/2019

Expiry date: December 2022

Contents

Contents

Section Page

Document summary sheet

1 Overview 1

2 Scope & Associated Documents 3

3 Background 4

4 What is new in this version? 4

5 Procedure 4

6 Roles and responsibilities 6

7 Monitoring document effectiveness 6

8 Abbreviations and definitions 6

9 References 6

10 Appendices 7

11 Document Control Information 28

12 Equality Impact Assessment (EqIA) screening tool 29

Group arrangements:

Salford Royal NHS Foundation Trust (SRFT)

Pennine Acute Hospitals NHS Trust (PAT)



1. Overview (What is this procedure about?) Nail surgery is a procedure undertaken by HCPC registered Podiatrists under local anaesthetic. The procedure involves removal of part or all of a toe nail and is the most common surgical procedure for treating ingrown toenails.

• Nail surgery should be performed on acute O/C toe nails within 4 weeks of initial presentation and within 8 weeks for a non-urgent problem. This excludes exceptional circumstances for example, when a patient’s safety may be compromised

• Nail Surgery will be performed at 2 designated nail surgery sites:

Ordsall Health Surgery

Salford Royal Foundation Trust (SRFT) Podiatry Department

Only in exceptional circumstances nail surgery may be conducted at other health centres and clinics, this is at the Podiatry Manager’s /Consultant Podiatrist’s discretion

• Patients who require nail surgery must be assessed for nail surgery within three visits of the presenting problem being recorded. The documentation paperwork to be used (Appendix 1) includes guidance to aid the completion of the assessment. The nail surgery assessment can also be completed on EPR/Sunrise. The nail surgery leaflet which includes the risks and

benefits must be given out once the assessment has been completed. • The consent form must be completed and signed at the assessment appointment, as per trust policy. The consent should be confirmed on the day of the procedure and the Podiatrist should

confirm the consent by a signature. The patient must be offered a copy of the consent form on the day of surgery. This should be explained fully to the patient at the assessment. • Patients should also be provided with the local anaesthetic patient information leaflet

applicable to the agent to be used (Appendix 2) • All parts of the assessment need to be completed and dated by the Podiatrist undertaking the assessment.

• The procedure must be carried out within 3 months of the assessment being completed. If the assessment expires prior to the procedure being completed the assessment must be re-completed.

• Nail surgery must be carried out with assistance and not as a lone practitioner. • The Podiatrist must be responsible for any assistant / students working under their supervision

• All Podiatrists should consider the patient’s general health, any co-morbidities, age and type of patient in relation to necessity for nail surgery e.g. age, health and clinical need for the procedure, potential risks and contraindications

• Before the procedure is undertaken the local safety standards for invasive procedures (locSSIPS) (appendix 3) checklist must be completed on the day of the procedure as this is a mandatory standard.



• Podiatrists should complete the nail surgery referral form and send the completed assessment and consent form along with any supporting documentation / correspondence to the Triage

Team. The referral will then be triaged and booked into an appropriate nail surgery clinic. If the patient is deemed increased risk by the triage team/referring clinician, the patient will be booked an appointment for a review with a Band 7 podiatrist for an Advanced Vascular

Assessment to include a toe pressure assessment. (Appendix 4) Low risk patients suitable for nail surgery with a band 5 clinician must fall within the following criteria:

• Patients with no relevant medical conditions

• Patients with palpable foot pulses, no PAD or distal vessel disease

• Children over 12 years (Discretional)

Increased risk patients suitable for nail surgery with a Band 6/7 Clinician include:

• Low / increased risk patients with diabetes

• Patients with controlled/uncontrolled rheumatological conditions

• Patients on anticoagulant treatment following communication with appropriate

consultant / anticoagulation nurse

• Patients with Peripheral Arterial Disease

• Patients with complex medical histories

• Patients with connective tissue disorders

• Patients with a known history of Allergy to Anaesthetics.

• Patients with renal disease

If in doubt about the appropriateness of nail surgery for any patient, please liaise with the Band 7 nail surgery nominated lead before proceeding.

2. Scope (Where will this document be used?)

This document should be used by the following:

• All Podiatrists who undertake nail surgery • Assistants who support nail surgery • All Podiatrists referring a patient for nail surgery.



3. Background (Why is this document important?)

This policy aims to give clear guidance and provide standardisation of the practice of nail

surgery throughout the department. The nail surgery procedure must be followed in order to maintain high standards of practice.

4. What is new in this version?

Procedure reviewed and updated with new guidance for increased/high risk nail surgery referrals.

5. Procedure

Before the procedure is undertaken the local safety standards for invasive

procedures (locSSIPS) checklist must be completed as this is a mandatory standard (appendix 3)

Review the patients’ medical history, and medication confirm the consent and

explain the procedure to be performed

When ready to proceed, lie the patient down unless they request not to, ensuring

they are as comfortable as possible

Prepare the patient’s toe for the local anaesthetic with a disinfectant skin wipe Medipal.

Using all normal decontamination procedures and PPE, administer the LA ensuring the maximum safe dose is not exceeded (appendix 8) using Mepivacaine plain, Lidocaine plain or Bupivacaine plain

Once ready to proceed apply apron, wash hands with antibacterial soap and put on sterile gloves using ANTT procedure.

Ensure analgesia has been achieved. Ask the patient to close their eyes, using a blacks file or similar, demonstrate using an area that is not anaesthetised. Repeat the same action on the anesthetised area advising the patient they may feel pressure in this area but not pain. Do not proceed until full anaesthesia has been

achieved

Apply the tourniquet to the toe. If a tourniquet is being used for the whole procedure, the tourniquet should be positioned distally and moving proximally to

ensure a blood less field. Make a note of the time it was applied

For a partial nail avulsion

o a) Loosen the sulcus with a blacks file or equivalent.

o b) Insert the Thwaites nippers under the nail plate maintaining close contact

with the nail plate, push until the eponychium is reached. This will leave a straight edge and cut



o c) Take the beaver handle with blade inserted and continue through the cut line made by the Thwaites nippers underneath the proximal nail fold,

ensuring the whole length of the nail is separated o d) Place forceps on the piece of nail which requires removing, clamp and

excise the nail, rotating the forceps towards the middle of the nail.

For a total nail avulsion

o a) loosen the whole nail with an elevator) remove the whole nail rotating towards the centre of the nail plate

If there is hypergranulation tissue present this may be resected with a scalpel or tissue nippers at the Podiatrist’s discretion

Clean the nail bed with a black’s file and a swab clean the nail bed ensuring the

area being phenolised is free from blood or loose tissue. Clean the sulcus and free edge of the nail to ensure no nail fragments remain

For both partial and total nail avulsions phenol (please see phenol SOP appendix

10) should be applied using a sterile pipette to drop liquefied phenol down the sulcus, and then use the black’s files to scarify the sulcus for two minutes. Cleanse the area with a sterile swab then repeat timing the application for one minute

Irrigate the area with Industrial methylated spirit and/or dry the sulcus with a gauze swab

Remove the tourniquet and record the total time the tourniquet was on the toe on the operation report form, the tourniquet must not stay on the toe for longer than 20 minutes. Document circulatory return / capillary refill

Ensure the toe has stopped bleeding, dress the wound with Atrauman or non-adhesive dressing/alginate/low adherent dressing and tubegauze

Ensure the patient is feeling well and sit them up in the chair

Put the leg rests down on the patient chair to ensure the toe has stopped bleeding

Provide the patient with the post-operative report and explain potential problems

listed on the form. Once you are happy there is no evidence of immediate post-operative complication e.g. bleeding, patient feeling faint, unwell etc. the patient can depart. The patient should be given a follow up appointment within 72 hours

Fill in the operative report

Send the post-operative letter to the GP (Appendix 5)



5. Roles & responsibilities

Band 5 Podiatrists must complete the relevant competencies with the supervision of an experienced Band 6 podiatrist prior to conducting nail surgery with a Band 5 colleague or Podiatry assistant.

6. Monitoring document effectiveness

The procedure does not require monitoring

7. Abbreviations and definitions

O/C- Onychocryptosis – ingrowing toe nail LocSSIPS - Local safety standards for invasive procedures

8. References

Baran R, Haneke E: Matricectomy and nail ablation. Hand Clin 18: 693, 2002

de Bengoa Vallejo R. B., Iglesias M. E. L., Gomez R. S., and Jules K. T.

Gauze Application of Phenol for Matrixectomy J Am Podiatry Med Assoc, September 1,

2008; 98(5): 418 - 421.

Boberg J. S, Fredericksen M.S, Harton F. M: Scientific analysis of phenol nail surgery.

JAPMA 92: 575, 2002.

Boll, O.F. (1945) Surgical correction of ingrowing toenails. Journal of the American Podiatry

Association; 35: 8-9. Cited in Ceilly, R.I., and Collison, D.W., (1992) Matricectomy. Journal of

Dermatologic Surgery and Oncology; 18: 728-734.

Brown, J. (2004) Use of 89% phenol swabs in phenolisation of nail surgery wounds. It’s time

to focus on the future. Phenol EX Swabs. DLT, Surgery Solutions.

Rounding C, Hulm S: Surgical treatments for ingrowing toenails. Cochrane Database Syst

Rev 2: CD001541, 2000

Weaver T. D., Vy Ton M., and Pham T. V. Ingrowing Toenails: Management Practices and

Research Outcomes International Journal of Lower Extremity Wounds, March 1, 2004; 3(1):

22 - 34.

The Medicines and Healthcare products Regulatory Agency -

http://www.mhra.gov.uk/NewsCentre/CON051775



9. Appendices

Appendix 1 Nail Surgery Assessment Paperwork

REFERRAL DATE: __________ REFERRING PODIATRIST: ____________________

PATIENT NAME:________________________________________________________

NHS NO: _________________________________ DOB: ___________________________

CONTACT NUMBER (Preferably Mobile Number): _____________________________

Please ensure the telephone numbers are correct on patient centre for the telephone review.

PROCEDURE CONSENTED FOR: ____________________________________________

________________________________________________________________________

STATE OF TOE AT ASSESSMENT: Intact: O/C / Hypergran: Infected:

Is the patient willing to be treated by a student YES: NO:

Notes tracked to Cleveland House:

All pre op paperwork completed:

Pre op Patient information given:

Consent form signed:

Does the patient have any holidays booked (please specify) : ________________________

_________________________________________________________________________

FOR OFFICE USE:

LOW RISK BAND 5: INCREASED RISK BAND 6: HIGH RISK BAND 7:

Nail Surgery APPT DATE: ___________________________________________________ 24 – 72 hour clinic APPT DATE: ______________________________________________

8 week telephone review entered on waiting list: REFERRALS SEND TO: Podiatry Triage Team, Cleveland House, 224 Eccles Old Road, M6 8AL

PATIENTS NAME………………………………… NHS No : ……………………….



CHECKLIST FOR NAIL SURGERY DOCUMENTATION

Initial evaluation Date…………………….

L.A. Questionnaire Date………………………..

Risks/Benefits Date……………………….. Pre- Op Instructions Date………………………..

Consent form signed Date………………………..

Operation Report Completed Date………………………..

Post -Op Instructions Date……………………….. Prescription Request Date………………………..

Post-Op G.P. Letter Date…………………………

Follow up Dressing Booked Date:………………………… Time:…………………………

Clinic: ………………………. If Diabetic Latest HbA1c …………………….…………………………………………..

Operating Podiatrist……………………………………………………………………… Date of surgery: ………………………………. Location: …………………………….



Nail Surgery Assessment Form

Name…………………………………………………………… NHS No……………………………

Address…………………………………………………………………………………………………..

Postcode ………………………………… Tel No……………………………………………………..

D.O.B.………………………………… G.P……………………………………………………………..

Medical History……………………………………………………………………………………………

………………………………………………………………………………………………………………..

………………………………………………………………………………………………………………. ALLERGIES: ………………………………………………………………………………………………

Medication…………………………………………………………………………………………………

………………………………………………………………………………………………………………..

……………………………………………………………………………………………………………….. ……………………………………………………………………………………………………………….

Presenting Problem Right _______________Med/Lat/TNA Left _____________Med/Lat/TNA

Duration of Problem Right______________________ Left_____________________

Vascular Assessment

Neurological Assessment

Signed…………………………………………………Date ………………………………………………..

Printed ………………………………………………… Designation …………………………………….. Patient Name ___________________________ NHS No _______________________

Pulses: Dorsalis Pedis Palpable Absent Palpable Absent

Posterior Tibilalis Palpable Absent Palpable Absent

Temperature Normal Cold Hot Normal Cold Hot

Intermittent Claudication Yes No Yes No

10G Monofilament No Loss Loss to:

______________

No Loss Loss to:

______________



WOUND ASSESSMENT ( circle and use numbers for multiple toes)

Base descriptions sloughy granulating necrotic macerated hypergranulation intact other Cellulitis Extent (Mark with pen) none localised (<2cm) extensive (>2cm) tracking

Heat normal warm hot

Exudate extent none slight moderate heavy

Exudate Type none blood green yellow serous other

stained

Is the Wound Clinically Infected? No Yes

Does the Patient Require Antibiotics? No Yes Specify____________________

Other observations / remarks ………………………………………………………………….………….

………………………………………………………………………………………………………………….

……………………………………………………………………………………………………………..……

………………………………………………………………………………………………………………….. …………………………………………………………………………………………………….…………….

…………………………………………………………………………………………………….…………… Advice to Patient………………………………………………………………………………………………

…………………………………………………………………………………………………...…………….. ………………………………………………………………………………………………………………….

Planned Review & Action………………………………………………………………………...………….

……………………………………………………………………………………………………………….....

…………………………………………………………………….……………………………………………

.:…………………………………………………………………………………………………………..…….

Signed……………………………………………………Date …………………………………………

Printed ………………………………………………… Designation : PODIATRIST

LOCAL ANAESTHETIC QUESTIONNAIRE



To be completed in all cases, where a patient is being assessed regarding suitability for administration of Local Analgesia and surgery. The questionnaire is designed to be used as an aid only. The final decision is the responsibility of the administering Podiatrist.

Patient Name DOB

NHS Number

1 Do you have diabetes? Yes No

2 Do you have a Connective Tissue Disorder (Rha / SLE / Scleroderma) Yes No

3 Do you have a circulatory disorder? Yes No

4 Have you had a heart attack within the last 6 months (if y es def er surgery ) Yes No

5 Do you have problems with your breathing? Yes No

6 Do you have epilepsy? Yes No

7 Have you ever had Rheumatic Fever? Yes No

8 Do you have jaundice, liver or kidney disease? Yes No

9 Do you have any allergies to food, medicine or other substances? Please state: ……………………………………………………………………………………

Yes No

10 Have you ever been given a local anaesthetic before (eg at the dentist)? Yes No

11 If yes, did you suffer any adverse reaction? Yes No

12 Have you ever had abnormal bleeding after dental extraction, surgery or injury? Yes No

13 Are you an expectant mother? Yes No

14 Date of last menstrual period ____________________

15 Do you have any other problems relating to your health? Please State: ……………………………………………………………………………………

Yes No

PODIATRIST: Where any doubt exists, regarding patient suitability, the patient’s general practitioner must be consulted.

Signed…………………………………….… Date …………………………………………… NAIL SURGERY – OPERATION REPORT

Patient Name ……………………………….. NHS No ……………………………..

Procedure(s) Performed:……………………….…………………………………………

Comments:



……………………………………………………………………………………………….

LOCAL ANALGESIA AGENT (Delete as appropriate) MEPIVICAINE HYDROCHLORIDE /

BUPIVICAINE HYDROCHLORIDE / LIDOCAINE HYDROCHLORIDE Strength ……………………… Site(s) ……………………………………………………

Volume (Record separately for each toe) R: ……………………… L: …………………………….

Batch number ………………………………….. Expiry Date …………….

Total Dosage ………………………………………………………………. mg.

State of toe(s) prior to Operation ……………………………………………..

…………………………………………………………………………………………………

Details of Procedure

1.) Procedure Explained 2.) Consent form Confirmed and signed

3.) LA questionnaire checked 4.) LA Administered

5.) Pre op cleanser ……………………. 6.) Tourniquet(s) applied? YES/NO

Tourniquet Duration (Record separately for each toe)

i) Toe: ________ On:_________ Off: _________ Total Time ________Mins

ii) Toe: ________ On:_________ Off: _________ Total Time ________Mins

iii) Toe: ________ On:_________ Off: _________ Total Time ________Mins 8.) Phenol – record batch number ………………………………………………….

9.) Number of pipetted drops of phenol used: …………………………………….. 10.) Duration of Application of Phenol : …………………………………………….

11.) Nail bed: dried with gauze Irrigated with IMS 12.) Tourniquet removed Signed …………………. Print ………..………….. (Podiatrist) Date: ………………

Patient Name ……………………………….. NHS No …………………………..



Circulatory Return

Toe (i) _______ Secs Comment ____________________________________

Toe (ii) _______ Secs Comment ____________________________________

Toe (iii) _______ Secs Comment ____________________________________

Post Operative Dressing(s) …………………………………………………

……………………………………………………………………………………….………

……………………………………………………………………………………………….

REMARKS:

Signed ………………………………….………… Date ……………………………….

Print …………………………………………….… Designation : PODIATRIST

L.A. Administered by (if different from above)

Signed ……………………………….…………… Date …………..…………………….

Print …………………………………………….… Designation ……..………………….

Assistant (signed) ……………………..…..…… (Print) ……..………………………….



Post-Op Evaluation - Nail Surgery Sheet number………

Name:…………………………………………………… NHSNo:…………………………… Presenting Problem

Right__________________Med/Lat Left_____________Med/Lat Duration of Problem

Right__________________Weeks Left_____________Weeks

Clinical signs and symptoms (Use numbers for multiple toes)

Base descriptions sloughy granulating necrotic macerated hypergranulation

intact other

Cellulitis Extent none localised (<2cm) extensive (>2cm) tracking (Mark with pen)

Heat normal warm hot very hot

Exudate extent none slight moderate heavy

Exudate Type none blood green yellow serous other

stained Is the Wound Clinically Infected? No Yes

Does the Patient Require Antibiotics? No Yes

Specify__________________ Other observations / remarks…………………………………………………………………….

……………………………………………………………………………………………………… ……………………………………………………………………………………………………

Dressing Regime……………………………………………………………………………….. ………………………………………………………………………………………………………

Advice to Patient………………………………………………………………………………… ………………………………………………………………………………………………………

Planned Review………………………………………………………………………………. ………………………………………………………………………………………………………

Signed………………………………………………Date…………………………………………

Printed …………………………………Designation ………………………………..



Appendix 2 Local Anaesthetic Patient Information Leaflets

Patient information leaflet Scandonest 3% Plain

Read all of this leaflet carefully before you are administered this medicine.

- Keep this leaflet. You may need to read it again. - If you have any further questions, ask your Podiatrist. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your dentist.

In this leaflet:

1. What is SCANDONEST 3%PLAIN and what is it used for. 2. Before you are administered SCANDONEST 3% Plain.

3. How SCANDONEST 3%PLAIN is used. 4. Possible side effects. 5. Further Information.

1. What SCANDONEST 3%PLAIN is used for.

SCANDONEST 3%PLAIN is given by injection to cause loss of feeling before and during Podiatry procedures. It contains one active ingredient : Mepivacaine Hydrochloride, a local anaesthetic which

prevents pain. SCANDONEST 3%PLAIN is for children over 4 years old and adults. Only a Podiatrist can administer this product. 2. Before you use SCANDONEST 3%PLAIN

Do not use SCANDONEST 3%PLAIN

If you are allergic(hypersensitive to the active ingredient (Mepivacaine Hydrochloride) or any of the other ingredients(refer to section 5)

You are allergic to local anaesthetics called amide type anaesthetics

In children under 4 years old Take special care with SCANDONEST 3%PLAIN

Before receiving this medicine, tell your Podiatrist if:

You have problems with your heart

You have problems with your liver

You have problems with your kidneys

You have a severe infection or an inflammation in the area where the injection will be done Using other medicines

Please tell your Podiatrist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your Podiatrist should take special attention if you are taking the following medicines:

Medicines used to reduce patient apprehension (e.g. sedatives). In that case, the dosage of

anaesthetic should be reduced. Pregnancy and breast feeding

This medicine should be used with caution during pregnancy or breast feeding. Ask your Podiatrist for advice before taking any medicine. Driving and using machines

If you experience side effects, including dizziness or blurred vision, you should not drive or operate machinery until these defects have disappeared. Important information about some ingredients of SCANDONEST 3%PLAIN

SCANDONEST 3%PLAIN contains less than 1mmol (23mg)sodium per cartridge, i.e. essentially “sodium free”



3.How SCANDONEST 3%PLAIN is used

Your Podiatrist will explain to you why you are being treated with SCANDONEST 3%PLAIN. They will choose the formula and adjust the dosage according to your age, health, weight and the procedure required. One cartridge is usually sufficient but your Podiatrst may give a greater

quantity. SCANDONEST 3%PLAIN is injected into the base of the toe. It should not be injected into a blood vessel. If your Podiatrist uses more SCANDONEST 3%PLAIN than he should.

If you think you may have been given too much of this injection and feel unwell (see section 4,

possible side effects), tell your Podiatrist. 4.Possible side effects

Like all medicines, SCANDONEST 3%PLAIN, can cause side effects, although not everybody gets them. While you are in with your Podiatrist they will carefully follow the effects of SCANDONEST 3%PLAIN. However, some of the effects may not be noticed or appear later.

Check with your Podiatrist, Doctor or Pharmacist if any of the following side effects occur: General effects: feeling nervous, nausea, vomiting, headache, dizziness, twitching,

apprehension, confusion, drowsiness, malaise, agitation, convulsions, unconsciousness, faint Effects on your senses: trembling, light headidness, buzzing in the ears, blurred or double

vision, sensation of heat, cold or numbness Effects on your lung: difficulty in breathing

Effects on your heart and blood vessels: slow heartbeats, low blood pressure

Effects on your skin: skin rash, hives or itching or severe allergic reaction (including swelling

of the face, lips and/or tongue, difficulty in breathing). You may develop more severe reactions such as convulsions and reduced level of consciousness with possible arrest of breathing or heart. Emergency medical help should

immediately be called.If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your Podiatrist. 3. Further Information

What SCANDONEST 3%PLAIN contains.

Active substance: each ml of solution for injection contains 30mg of Mepivacaine hydrochloride.

The other ingredients are: sodium chloride, sodium hydroxide and water for injection. What SCANDONEST 3%PLAIN looks like and content of the pack.

It is a clear and colourless solution for injection SCANDONEST 3%PLAIN is available in boxes containing 50 cartridges of 2.2ml Marketing authorisation holder Manufacturer

Septodont Ltd, Units R&S Septodont Orchard Business Centre 58 Rue du Pont de Creteil St Barnabas Close 94100 Saint-Maur-des- France FossesAllington, Maidstone

Kent ME16 0JZ – UK Patient Information Leaflet Lidocaine

Lidocaine Injection BP 0.5% w/v Solution for Injection

Lidocaine Hydrochloride

This leaflet will provide you with important information about your medicine. Please



read it carefully before you receive your injection. The leaflet contains a summary but not all of the information aboutLidocaine Injection BP. If you require any

further information or you are unsure about anything, ask your physician or pharmacist. ABOUT YOUR MEDICINE

The active ingredient in this medicine is Lidocaine. This is the new name for Lignocaine. The active ingredient itself has not changed.Lidocaine Injection BP is a clear, colourless, sterile

solution for injection containing the active ingredient Lidocaine Hydrochloride. Lignocaine Injection BP 0.5% w/v Solution for Injection . Each 10ml of solution contains 50mg(5mg/ml) Lidocaine Hydrochloride. Inactive ingredients: Sodium Chloride, Sodium Hydroxide (as a 10% w/v solution) or dilute

Hydrochloric Acid in Water for Injections. Pack Sizes: Each carton contains 10 glass ampoules. Not all pack sizes may be marketed. Type of medicine: Lidocaine Hydrochloride is a local anaesthetic. It produces loss of feeling or sensation confined to one part of the body (local anaesthesia). Lidocaine belongs to a group of

medicines called amide-type local anaesthetics. Holder of Product Authorisation: Mercury Pharmaceuticals (Ireland) Ltd 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland. Name of the Manufacturer: B BRAUN Melsungen AG, Mistelweg 2,12357, Berlin, Germany

Product Authorisation Numbers: 0.5% w/v 10ml: PA 73/112/1 USES

Lidocaine Injection BP may be used to produce local anaesthesia by injection of the solution into or around a peripheral nerve or network of nerves. It may also be used to relieve pain by

administering the solution into the vein in a limb that has been isolated from the circulation by means of a tourniquet. BEFORE YOU RECEIVE YOUR MEDICINE

Before you receive this injection, make sure to tell your physician if

• you are allergic to lidocaine or to any other amide-type of local anaesthetic • you are pregnant, likely to be pregnant, or breast feeding • you suffer from epilepsy, heart disease, breathing problems or a disease of the liver

or kidneys • you have an infection of the skin with pus near the site to be injected • you are taking any other medication,especially- beta-adrenoreceptor blocking agents(e.g.propranolol) - for the treatment of high blood pressure, angina(chest pain) or heart

attacks Cimetidine - to treat hyperacidity, stomach &duodenal ulcers



acetazolamide - to treat glaucoma(increased pressure in the eye) thiazides & loop diuretics - drugs to increase your urine output

antiarrhythmics - drugs to treat abnormal heart rhythms quinupristin /dalfopristin - an antibiotic suxamethonium - a muscle relaxant Driving or operating machinery: If you intend to drive or operate machinery following an

injection of lidocaine, ask your physician for advice about when it would be safe to perform these tasks. HOW YOUR MEDICINE IS ADMINISTERED

The site of injection will depend on the area to be anaesthetised. Your physician will decide on

the most suitable dosage and this will depend on the site of injection, the procedure used and your response to the injection. The maximum dose is 3mg per kg bodyweight or 200mg,whichever is the lower. Children, elderly patients or patients in a weak condition require smaller doses, depending on

their age and physical condition. What to do in case of a missed dose or an overdose: If you think that you may have missed a dose, or that you may have been given too much of this injection, tell your physician. AFTER YOU RECEIVE YOUR MEDICINE

Lidocaine is generally well tolerated. Like other amide-type local anaesthetics, lidocaine may occasionally cause unwanted effects. Only in rare cases have amide-type local anaesthetics been associated with allergic reactions (such as a skin rash, shortness of breath or fall in blood pressure).

Serious side-effects are rare, but may occur in case of an over dosage or if the solution is rapidly absorbed from the injection site or if it is accidentally injected into a blood vessel. In these circumstances symptoms such as nervousness, dizziness, buzzing in the ears, blurred vision, shakiness, twitching, drowsiness, feeling breathless or feeling faint may occur. Lidocaine

may result in abnormal amount of methemoglobin (a form of hemoglobin in blood) which may cause bluish discoloration of skin, headache, shortness of breath, malaise and fatigue. Other side effects include: • changes in the rhythm and speed of the heart.

• pain at the injection site, or numbness or loss of power after the effects of the injection should have worn off • difficulty in passing water • feeling sick or being sick (nausea or vomiting)

• drowsiness, dizziness, mood changes • vision difficulties • convulsions • low blood pressure

After spinal injection of lidocaine, you should tell your doctor if you experience any of the following side effects: • pain or numbness in the back or lower legs • difficulty in walking

• problems controlling your bladder or bowels • faintness of light headed feeling • slow heart or pulse rate



If you experience any of these side-effects, or if you notice any unwanted effects that are notmentioned here, tell your physician. Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions preferably through the online

reporting option accessible from the IMB homepage. A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’, in addition to the traditional post-paid ‘yellow card’ option. Ireland

Pharmacovigilance Section Irish Medicines Board Kevin O’Malley House Earlsfort Centre

Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 67625177

Website: www.imb.ie e-mail: [email protected] How to store Lidocaine Injection

Keep Lidocaine Injection out of the sight and reach of children.

Do not use Lidocaine Injection after the expiry date which is stated on the carton and ampoule label after Exp. The expiry date refers to the last day of that month. Do not store above 25°C. Keep the ampoules in the outer carton in order to protect from light.

This product should be used immediately after opening. If only part used, discard the remaining solution. For single use only. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist

how to dispose of medicines no longer required. These measures will help protect the environment. Mercury Pharmaceuticals (Ireland) Ltd 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.

Date of last revision: October 2013



Patient information leaflet Bupivicaine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.

Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. The name of your medicine is Bupivacaine Hydrochloride 0.25% w/v Solution for Injection, Bupivacaine Hydrochloride 0.5% w/v Solution for Injection. It will be referred to as Bupivacaine

Hydrochloride Injection for ease hereafter. In this leaflet: 1. What Bupivacaine Hydrochloride Injection is and what it is used for 2. Before you are given Bupivacaine Hydrochloride Injection

3. How Bupivacaine Hydrochloride Injection is given to you 4. Possible side effects 5. How to store Bupivacaine Hydrochloride Injection 6. Further information 1. WHAT BUPIVACAINE HYDROCHLORIDE INJECTION IS AND WHAT IT IS USED FOR

Bupivacaine belongs to a group of medicines called amide-type anaesthetics. Bupivacaine Hydrochloride injection is used to numb (anaesthetise) parts of the body. It is used to stop pain happening or to provide pain relief. It can be used to:

- Numb parts of the body during surgery in adults and children above 12 years - Relieve pain in adults, infants and children above 1 year of age. Bupivacaine Hydrochloride Injection may be used as follows: - as a local injection to produce numbness at the site of injection

- injected around a nerve to block the nerve and relieve pain - injected around the spinal cord as an epidural to prevent or relieve pain, e.g. in labour, surgical operations including Caesarean section, and for post-operative pain. 2. BEFORE YOU ARE GIVEN BUPIVACAINE HYDROCHLORIDE INJECTION

You should not be given this medicine if:

• you know you are allergic to bupivacaine or to any other amide-type of local anaesthetic, or to any of the other ingredients (see Section 6 of this leaflet) • you are to be injected in a vein of the hands or legs. (Bier’s block).

• Adrenaline containing bupivacaine should not be given for special techniques (like penile block, Oberst block) to numb the part of the body where areas with end arteries are affected. You should not be given this Injection as an epidural if:

• you have an infection of the skin with pus at or near the site to be injected

• you have inadequate circulation of blood to the heart, sudden loss of blood or weakness of the heart that causes low blood pressure, a weak rapid pulse, sweating and confusion • you have problems with the clotting of your blood or are taking any anticoagulant drugs that thin the blood

• you are suffering from any infection, disease or tumour of the brain or spinal cord • you have bleeding inside the head (intracranial haemorrhage) • you have increased pressure within the brain. Speak to your doctor or midwife if one of these applies to you before you are given this

medicine. Take special care and tell your doctor or midwife if:

• you suffer from any liver and kidney problems • you suffer from any heart problem, particularly if it affects the heart rate

• you suffer from severe shock or low blood pressure • you have breathlessness or restriction to breathing from fluid or a large tumour in the abdomen



• you have accumulation of fluid around the lungs • you are elderly (senile) or in poor health

• you are in the late stages of pregnancy • you suffer from blood poisoning (septicaemia) • you have high blood pressure during pregnancy • you have problems with the circulation of blood to the brain

• you have excess fluid in the womb during pregnancy (hydramnios) • you have a tumour of the ovary or the womb • you have accumulation of excess fat in your body • you have a decrease in the amount of fluid circulating in your body causing symptoms such as

sweating, mental confusion, dizziness or fainting (for example, due to dehydration or severe blood loss). Taking other medicines:

Tell your doctor or midwife before you are given this medicine if you are taking or have recently

taken any other medicines, including medicines obtained without a prescription. Some drugs can interact with Bupivacaine Hydrochloride Injection which can significantly alter their effects. These drugs include: • lidocaine, amiodarone, mexiletine (or any other medicine with local anaesthetic effect) for

controlling the heart’s rhythm. Some drugs may increase the risk of side effects with Bupivacaine Hydrochloride Injection in certain situations. These drugs include: • an anticoagulant e.g. aspirin (to reduce the clotting power of the blood)

• medicines to lower your blood pressure including betablockers, e.g. atenolol, bisoprolol. If you are already taking one of these medicines, speak to you doctor or midwife before you receive Bupivacaine Hydrochloride Injection. Pregnancy and breastfeeding:

Tell your doctor/midwife before you are given this medicine if you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding. There is no evidence of harmful effects in pregnancy or breastfeeding. However as with all drugs, Bupivacaine Hydrochloride Injection should only be given in early pregnancy if absolutely necessary.

In children < 12 years as some injections of Bupivacaine Hydrochloride injection in order to numb parts of the body during surgery are not established in younger children. Bupivacaine Hydrochloride injection is not established in children < 1 year. Driving and using machines:

Certain areas of your body will be numb for about 2-4 hours after having this medicine. If this is likely to affect your ability to drive or use machinery you should wait for the effect to wear off. In general, it is wise to ask your doctor whether it is safe to drive. 3. HOW BUPIVACAINE HYDROCHLORIDE INJECTION IS GIVEN TO YOU

Bupivacaine Hydrochloride Injection should only be administered by a doctor who will, in the case of an epidural injection, have the necessary knowledge and experience in the technique of epidural anaesthesia. Before administrating an epidural Injection, your doctor may inject a test dose of Bupivacaine

Hydrochloride Injection to ensure that the solution is not directed into a blood vessel. Your doctor will decide on the most suitable dosage for your particular case and may decide to reduce the dose if you are young, or elderly, or in a weak condition. If you are concerned about how much of this medicine you have received, speak to your doctor immediately. Use in children and adolescents

Depending on the type of required analgesia Bupivacaine Hydrochloride injection is injected slowly either into the epidural space (part of the spine) or other parts of the body by an anaesthesiologist experienced in paediatric anaesthetic techniques. Dosage depends on the

age and weight of the patient and will be determined by the anaesthesiologist. If you have any further questions on the use of this product, ask your doctor or pharmacist.



4. POSSIBLE SIDE EFFECTS

Like all medicines, Bupivacaine Hydrochloride Injection can sometimes cause side effects,

although not everyone gets them. All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor

immediately.

Other serious side effects are also rare, but may occur if too much Bupivacaine Hydrochloride Injection is given or if the drug is unintentionally injected into a blood vessel. If you notice any of the following effects inform your doctor immediately. Other possible side effects: Very common (affects more than 1 in 10 people):

• Low blood pressure. This might make you feel dizzy or light-headed • Feeling sick(Nausea). Common (affects 1 to 10 people in 100)

• Being sick (Vomiting) • Feeling dizzy • Pins and needles

• High blood pressure • Slow heart beat • Problems in passing water • Drooping of the upper eyelid, sunk in eye, flushing of the face (Horner’s syndrome) are more

commonly experienced in pregnant women. Uncommon (affects 1 to 10 people in 1000)

• Feeling light-headed • Fits

• Ringing in the ears or being sensitive to sound • Difficulty in speaking • Numbness of the tongue • Blurred sight

• Loss of consciousness • Shaking • Twitching of your muscles. Rare (affects 1 to 10 people in 10,000)

• Double vision • Nerve damage that may cause changes in sensation or muscle weakness. This may include peripheral nerve damage • A condition called arachnoiditis (inflammation of the membrane that surrounds the spinal

cord). The signs include a stinging or burning pain in the lower back or legs and tingling, numbness or weakness in legs • Spinal cord injury (paraplegia)

• Partial loss of movement (paresis) • Uneven heart beat or stopped heartbeat. This could be life threatening • Slowed or stopped breathing. Possible side effects seen with other local anaesthetics which might also be caused by

Bupivacaine include:

• Problems with your liver enzymes. This may happen if you have long-term treatment with this medicine • Damaged nerves. Rarely this may cause permanent problems

• Blindness which is not permanent



• Problems with the muscles of eyes that are long-lasting. This may happen with some injections given around the eyes. Additional side effects in children and adolescents

Adverse drug reactions in children are similar to those in adults. Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effect get serious or you notice any side effects not listed in this leaflet, please tell your

doctor or midwife. Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card

Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE BUPIVACAINE HYDROCHLORIDE INJECTION

Keep this medicine out of the sight and reach of children.

The solution should not be used after the expiry date printed on the ampoule and carton. The expiry date refers to the last day of that month. Do not store above 25°C. Keep the container in the outer carton in order to protect from light.

This medicine should not be mixed with any other drugs unless compatibility is known. The solution must not be stored in contact with metals e.g. needles or metal parts of syringes, as dissolved metal ions may cause swelling at the site of the injection. If only part of an ampoule is used, the remaining solution should be discarded.

The solution should not be used if it is discoloured in any way. 6. FURTHER INFORMATION

The active substance is bupivacaine hydrochloride. The other ingredients are sodium chloride and sodium hydroxide and water for Injection. What Bupivacaine Hydrochloride Injection looks like and contents of pack

Bupivacaine Hydrochloride Injection is a colourless or almost colourless, aqueous, sterile solution for injection and is available in two strengths: Bupivacaine Hydrochloride Injection 0.25%w/v. Each 1ml contains 2.5mg of anhydrous

bupivacaine hydrochloride. Bupivacaine Hydrochloride Injection 0.5%w/v. Each 1ml contains 5mg of anhydrous bupivacaine hydrochloride. Both product strengths are available as either:

• 10ml and 20ml clear glass ampoules in packs of 10 or • 10ml and 20ml individual sterile wrapped clear glass ampoules in packs of 10. Marketing authorisation holder

Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park,

Co Dublin, Ireland. Manufacturer

B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany. Alternative site

Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, United Kingdom This leaflet was last revised in April 2015.

100407/LF/021/04, 100409/LF/021/04



Appendix 3 LocSSIPS for Podiatry

Podiatry Surgery Checklist 1. SIGN IN (2 members of the team to collect the information w ith the patient/records before the procedure)

2. Time Out (to share the information w ith the team at the start of the procedure)

3. SIGN OUT (to be completed before the team leaves the room)

SIGN IN

Team has introduced themselv es?

Yes

Patient ID confirmed

Yes

Procedure confirmed with patient as per the consent form

Yes

Procedure site confirmed with the patient

Yes

Consent confirmed with patient

Yes

Is the anaesthesia checklist complete? Yes

Does the patient hav e a known allergy?

No Yes If yes please document

_____________________________________________

Antiplatelet/anticoagulant therapy adjusted?

N/A Yes If yes please document

_____________________________________________

Has antibiotic prophylaxis been giv en?

N/A Yes

Is the required equipment av ailable and in date?

Yes

Patient Details

Last Name:

Procedure consented for:

First Name:

Date of Birth:

NHS Number*

Date:



SIGN OUT Registered Practitioner v erbally confirms with the team:

Has the name and site of the procedure been recorded?

Yes

Has the batch number of the local anaesthetic been recorded? Yes

Has the batch number of the phenol been recorded? Yes

Post-Operativ e information giv en to patient

Yes

Signature of Operator: _________________________________ Designation: _______________________ Date: __________________

Signature of Assistant: _________________________________ Designation: _______________________ Date: __________________



Appendix 4 Nail surgery assessment guidance

Nail Surgery Assessment Pathway

Low Risk Nail Surgery •Foot pulses palpable

•No intermittent claudication

•Doppler signals clearly tri / bi

phasic

•No Ischaemic symptoms

•No significant medical history

•No relevant meds

•No previous allergies to LA/phenol

Complete nail surgery assessment and consent form and send to Cleveland

House for triaging. Please do not send nail surgery assessment for triaging until all

relevant correspondence from consultant has been received, if appropriate. If the

patient is diabetic, please ensure the latest HbA1c recorded is within the last three

months.

Patient presents for nail surgery pre-operative assessment by Podiatrist.

Baseline assessment.

Allergy Status Sensation Foot pulses Doppler signals Full Medical History Medication

Triage team to book review with High Risk Podiatrist

Lower limb vascular assessment including ankle and toe pressures, diagnosis / exclusion of PAD

and an individually agreed management plan to be formulated.

Consider proceeding with caution if

•Ankle <70mmHg or Toe <60mmHg and no suspicion of calcification

•Patient fully informed of risks (l iaise with vascular surgeon if required)

•Consider no tourniquet / phenolisation •Consider time of year

•If in doubt refer for surgical opinion (e.g

Winnigrad/Zadeks procedure)

Increased risk Nail surgery

•Foot pulses non-palpable

•Symptoms of intermittent claudication

•Doppler signals monophasic

•Any patient with diabetes, renal disease,

connective tissue disorders or Rheumatological disorders

•Irregular sound when listening with

doppler

**Any diabetic patient with an intact OC and elev ated glucose levels within

the last three months (abov e 64mmol/mol) should be considered

for conserv ative management as a

first line treatment option.

Complete nail surgery assessment

and consent form 3 and send to Cleveland House for triaging

ensuring nail surgery front sheet is

completed and included.

If in doubt regarding appropriateness of nail surgery for any patient, please liaise with high

risk Podiatrist specialising in nail surgery, before sending completed nail surgery

assessment to Cleveland House. Podiatrist who sees patient at initial assessment to book

review with High Risk Podiatrist if it is deemed appropriate by them, following discussion

regarding the patient.



Appendix 5 Post OP GP Letter

Podiatry Department Cleveland House

224 Eccles Old Road Salford M6 8AL

Date:

Dear Dr PODIATRY SERVICE

Re:

NHS No: D.O.B.

Address The following operative procedure(s) was performed on your patient:

Date of Procedure

Further treatment and care will be provided by me for this patient at:

until the wound has healed. Yours sincerely

Signed ………………………. Print…………………………………. Designation ……………………………………………



Document Control Information

All sections must be completed by the author prior to submission for approval

Lead Author: Name & Role Anne-Marie Jones

Lead author contact details:

[email protected] tel:206 3842

Consultation List the persons or groups who have contributed to this

procedure. (please state which Care Organisation)

Name of person or group Role / Department / Committee (Care Org) Date

Vikki Pestridge Operation Lead Podiatry 06/12/2019

Louise Berry Advanced Podiatrist 06/12/2019

Lindsay Jones Advanced Podiatrist 06/12/2019

Endorsement List the persons or groups who have seen given their support to this

procedure. (please state which Care Organisation)

Name of person or group Role / Department / Committee (Care Org) Date

Podiatry Triage Committee Podiatry 06/12/2019

Keywords / phrases: Nail surgery guidance

Communication plan:

Team meetings/face to face role out

Document review arrangements:

This document will be reviewed by the author, or a nominated person, at least once every three years or earlier should a change in legislation, best practice or other change in circumstance dictate.

This section will be completed following committee approval

Procedure Approval:

Name of Approving Committee: Podiatry Triage Committee

Chairperson: Anne Marie Jones

Approval date: 06/12/2019

Formal Committee decision (tick) Yes Chairperson’s approval (tick) Yes

mailto:[email protected]

tel:206



12. Equality Impact Assessment (EqIA) screening tool Legislation requires that our documents consider the potential to affect groups differently, and eliminate or minimise this where possible. This process helps to reduce health inequalities by identifying where steps can be taken to ensure the same access, experience and outcomes are

achieved across all groups of people. This may require you to do things differently for some groups to reduce any potential differences. 1a) Have you undertaken any consultation/ involvement with service users, staff or other groups in relation to this document?

No Please state:

1b) Have any amendments been made as a

result? Yes/No

Please Comment:

2) Does this procedure have the potential to affect any of the groups below differently or negatively? This may be linked to access, how the process/procedure is experienced, and/or

intended outcomes. Prompts for consideration are provided, but are not an exhaustive list.

Protected Group Yes No Unsure Reasons for decision

Age (e.g. are specific age groups excluded? Would the same process affect age groups in different ways?)

X

Sex (e.g. is gender neutral language used in the way the

procedure or information leaflet is written?) X

Race (e.g. any specific needs identified for certain groups such as dress, diet, individual care needs? Are interpretation and translation services required and do staff know how to book these?)

X

Religion & Belief (e.g. Jehovah Witness stance on blood

transfusions; dietary needs that may conflict with medication offered.)

X

Sexual orientation (e.g. is inclusive language used? Are there different access/prevalence rates?)

X

Pregnancy & Maternity (e.g. are procedures suitable for

pregnant and/or breastfeeding women?) x

Marital status/civil partnership (e.g. would there be any difference because the individual is/is not married/in a civil partnership?)

X

Gender Reassignment (e.g. are there particular tests related to gender? Is confidentiality of the patient or staff member maintained?)

X

Human Rights (e.g. does it uphold the principles of Fairness, Respect, Equality, Dignity and Autonomy?)

X

Carers (e.g. is sufficient notice built in so can take time off work to attend appointment?)

X

Socio/economic (e.g. would there be any requirement or expectation that may not be able to be met by those on low or limited income, such as costs incurred?)

X

Disability (e.g. are information/questionnaires/consent forms available in different formats upon request? Are waiting areas suitable?) Includes hearing and/or visual impairments, physical disability, neurodevelopmental impairments e.g. autism, mental health conditions, and long term conditions e.g. cancer.

X



Are there any adjustments that need to be made to ensure that people with disabilities have the same access to and outcomes from the service or employment activities as those without

disabilities? (e.g. allow extra time for appointments, allow advocates to be present in the room, having access to visual aids, removing requirement to wait in unsuitable environments, etc.)

X

3) Where you have identified that there are potential differences, what steps have you taken to mitigate these?

4) Where you have identified adjustments would need to be made for those with disabilities, what action has been taken?

5) Where the policy, procedure, guidelines, patient information leaflet or project impacts on patients how have you ensured that you have met the Accessible Information

Standard – please state below: ………………………………………………………………………………………………………………

EDI Team/Champion only: does the above ensure compliance with Accessible Information

Standard o Yes

o No

If no what additional mitigation is required:

Will this procedure require a full impact assessment? No Please State your Rationale for the Decision

(a full impact assessment will be required if you are unsure of the potential to affect a group differently, or if you believe there is a potential for it to affect a group differently and do not know how to mitigate against this - Please

contact the Inclusion and Equality team for advice on [email protected])

Author: Type/sign: Vikki Pestridge Date: 6/12/19 Sign off from Equality Champion: Date:

mailto:[email protected]