wmresearch.org.ukwmresearch.org.uk/wordpress/wp-content/uploads/2014… · web viewupper gie.g....

West Midlands Trainee Research in Anaesthesia and Intensive Care Network

AUDIT PROTOCOL

FULL TITLE

A national snapshot study of perioperative pain management in patients undergoing abdominal surgery in the

United Kingdom

SHORT TITLE

UK Perioperative Pain Study

CHIEF INVESTIGATORS

Paul Marriott, ST7 in Upper GI Surgery

Email: [email protected]

Charlotte Small, Research Fellow in Anaesthesia and Critical Care


Version No 1.4

Date: 10/11/2014

1

mailto:[email protected]



KEY CONTACTS

Paul Marriott, ST7 Upper GI Surgery, Queen Elizabeth Hospital Birmingham, Edgbaston, Birmingham, UK.


Charlotte Small, Research Fellow in Anaesthesia and Critical Care, Queen Elizabeth Hospital Birmingham,

Edgbaston, Birmingham, UK.


Olga Tucker, Consultant Upper GI Surgeon, Queen Elizabeth Hospital Birmingham, Edgbaston, Birmingham, UK.


Tony Whitehouse, Consultant in Anaesthesia and Critical Care, Queen Elizabeth Hospital Birmingham,

Edgbaston, Birmingham, UK.


This protocol was developed by members of the West Midlands Research Collaborative and the West Midlands

Research and Anaesthesia and Intensive Care Network with particular acknowledgment to:

Jaimin Patel, Ravinder Vohra, Debby Edwards… and the following Consultants: Joyce Yeung, David Beard,

Davinia Bennett, Suneel Desai, Thomas Pinkney

2






GENERAL INFORMATION

Short Title UK Perioperative Pain Study

Full Title A national snapshot study of perioperative pain management in patients

undergoing abdominal surgery in the United Kingdom

Sponsor University of Birmingham

West Midlands Research Collaboration

(www.wmresearch.org.uk)

Chief Investigators Paul Marriott/Charlotte Small

Website www.wmresearch.org.uk

Email [email protected]

Co-ordinating Centre Queen Elizabeth Hospital Birmingham

STUDY INFORMATION

Indication To investigate the variation in practice of perioperative pain management

for abdominal surgery in the UK

Design Prospective observational audit

Primary Outcome Following abdominal surgery; the incidence of poor pain control at 48 hours

using routinely collected pain scores.

Secondary Outcomes Rate of optimal pain control prior to leaving recovery.

Rate of an unplanned change to post-operative pain management.

Rate of planned referrals to an Acute Pain Service

Length of stay

Rate of all 30 day readmission and A&E attendances

Rate of post operative complications at 30 days using the Clavien Dindo

classification.

STUDY TIMELINES

Pilot Study August 2014

Main study period Any 2 week period (consecutive) - latest day of data collection being 1st

March 2015

Follow-up duration 30 days- to be completed by 2nd April 2015

Data Submission Latest by 30th April 2015

Data analysis May 2015

Results available 1st June 2015

3


Across the UK there is widespread variability in the approaches used to manage pain in patients

undergoing surgery. Nevertheless good perioperative analgesia is essential to optimise patient

outcomes.

This study aims to describe current practice in perioperative pain management following abdominal

surgery and to observe how pain control affects post-operative outcomes.

Data will be collected over two weeks using a multi-centre prospective observational design. The

study will be a collaboration between surgical and anaesthetic trainee networks.

Data to be collated will include:

Intraoperative and post operative analgesic techniques.

The surgical procedure.

The efficacy of postoperative pain control in recovery and for 48 hours after leaving

recovery.

30 day surgical complications and readmission rates.

Audit standards proposed by the Royal College of Anaethetists will be used to determine pain

management efficacy and 30 day surgical complications will be collated using the Clavien-Dindo1

classification .

A pilot study has been conducted within General surgery at 2 trusts to refine the study protocol,

nevertheless the premise of this study is relevant to all surgical specialities.

The intention is to use results to generate hypotheses for future collaborative cohort and

randomised studies that aim to evaluate the efficacy, safety and patient experience of perioperative

pain management.

1.Dindo D., Demartines N., Clavien P.A.; (2004) Classification of Surgical Complications: A New Proposal With Evaluation in a Cohort of 6336 Patients and Results of a Survey Ann Surg.; 244: 931-937

4

Abstract


INTRODUCTION

Across the UK there is widespread variability in the approaches to management of perioperative

analgesia in patients undergoing abdominal surgery. Consensus exists that pain should be monitored

regularly and managed promptly, nevertheless monitoring techniques and response depend on local

practice. Whilst many practitioners employ a multimodal technique, consensus suggests that there

remains discordance between the use of systemic opioid and local anaesthetic based techniques to

control severe postoperative pain (Walton et al., 2006). The lack of reliability of local anaesthetic

techniques, combined with their associated unwanted side effects, has encouraged the use of

other pharmacological approaches, such as anticonvulsants (Zhang et al., 2011; Tiippana et al.,

2007) and intravenous lidocaine (Yon et al., 2014). Variation in analgesic practice may be due to

individual experience, preference and not least due to the inconsistency in outcomes measured by

efficacy studies (Cowlishaw et al., 2012; Macintyre et al., 2005).

Although it is unclear and unproven what the best analgesic approach is for abdominal surgery,

there is widespread acceptance in the surgical and anaesthetic communities that adequate

perioperative analgesia is essential to optimise patient outcomes (Brennan et al., 2007).

Consequently, to enable the design of future prospective studies of analgesic regimes, novel

approaches or agents that may improve patient outcomes, it is necessary to understand how

effective current peri-operative analgesic approaches are.

We aim to perform a prospective multicentre observational study to determine the efficacy of

current perioperative pain management and its affect on patient outcomes.

The West Midlands Research Collaborative (WMRC) have delivered large scale collaborative projects

(Pinkney et al., 2013, Johnstone et al., 2013, 2013) and, in association with the West Midlands

Trainee Research in Anaesthesia and Intensive Care Network (WMTRAIN), it is anticipated large

patient numbers can be accrued over a short time period. The resultant data will allow exploration

of differences in management of perioperative analgesia across the cohort to identify areas of

practice variability that result in apparent differences in pain control efficacy and other patient

outcomes. Whilst not providing true evidence of efficacy or the impact of a single or combination of

approaches, we anticipate that the study will be hypothesis-generating, identifying areas of clinical

practice warranting further study in future randomised controlled trials.

5


RATIONALE OF PROPOSED AUDIT AND HYPOTHESIS

Variation exists in approach to perioperative pain management amongst hospital doctors and

centres across the UK. The impact of such variation on the efficacy of pain control for patients is

unclear.

Our hypothesis is that within the UK different practices are being adopted resulting in variation in

pain experienced by patients undergoing abdominal surgery and these variations affect surgical

outcomes.

5.0 OBJECTIVES

Following abdominal surgery, to measure the incidence of poor pain control (defined below) at 48

hours using routinely collected pain scores (primary aim).

To measure the differences in other perioperative and 30-day outcomes in patients with and

without poor pain control (secondary aim).

To describe current practice in perioperative pain management in adults undergoing elective and

emergency abdominal surgery in the UK.

This study will also be used to develop a standardised approach for data collection through the

patient perioperative pathway, facilitated and driven by collaboration between surgical, anaesthetic

and acute pain management teams. This collaborative approach will subsequently act as a template

for delivery of future projects between the rapidly evolving trainee research networks in surgery and

anaesthesia in the UK (Bhangu et al., 2013).

6


6.0 DESIGN AND METHODS

This study will be undertaken using a multi-centre prospective observational design.

Any UK hospital that provides elective or emergency general surgery will be eligible to collect data.

Being observational, this study will only collate data that is or should be routinely recorded as part of

normal practice. No intervention or alteration to a patients perioperative course will occur. Audit

standards proposed by the Royal College of Anaethetists (RCoA) will be used to determine pain

management efficacy (described below). Consequently each centre will need to register and gain

approval from the hospital's clinical audit department to participate.

Patient Criteria

Data from all eligible adult patients undergoing an emergency or elective general surgical procedure

over a predetermined two-week period will be recorded.

Inclusion criteria

18 years of age or over.

All patients undergoing a general surgical abdominal procedure that are expected to

remain in hospital for >24hours after leaving the operating theatre recovery room.

This includes multiple stage procedures e.g. 2 stage oesophagectomies.

Exclusion Criteria

Patients under 18 years of age

Patients who undergo an intended day case procedure.

Patients undergoing an organ transplant or surgery primarily for Gynaecological or

Urological pathology.

7


AUDIT STANDARDS

The RCoA have produced a compendium of audit recipes (Raising The Standard: 2012) to aid

continuous improvement in anaesthesia. Three audit standards from the Pain medicine section

(section 11) will be used to determine pain management efficacy with the measure of poor control

being the primary outcome measure:

• Optimal postoperative pain relief (< 4 on a 0 to 10 scale) is established for >95% of patients

before timely discharge from recovery.

• Isolated occurrence(s) of moderate or severe pain (Borderline control) in a 24 hour period

(<5% of patient days).

• Consecutive occurrence(s) of moderate or severe pain (Poor control- Primary outcome

measure) in a 24 hour period (0% of patient days).

Moderate pain is defined as 2/3 on a 0-3 scale and 4-6 on a 0-10 scale.

Severe pain is defined as 3/3 on a 0-3 scale and 7-10 on a 0-10 scale.

Pilot Study

A two day pilot study has been conducted in two trusts within the West Midlands to refine the data

collection pro forma and study protocol.

Data on 20 patients was collected with 6 (30%) having poor pain control within 48 hours of leaving

recovery. 3 of these 6 patients had a complication, which accounted for 50% of all complications

recorded.

Although data was collected on a small number of patients, these results do suggest audit standards

are not being achieved and that outcomes are worse in patients whose pain control is poor.

Consequently, these findings highlight the need for this observational study in this important area of

patient management/care.

8


The pilot has also demonstrated over a 2 week period, data on approximately 30-70 patients could

be collected per site. Previous studies conducted by the West Midlands, National and Medical

student collaboratives have collected and published data on up to 109 centres, meaning if a

conservative 25 centres participated data on between 750 and 1750 patients would be collected.

The study will be performed across eligible centres for a two week consecutive period. To maximise

data collection and participation, centres will have the option of deciding the consecutive 2 week

period they wish collect data. The data collection period will close at 0759 on Monday 2nd March

2014 (meaning the last 2 week period for collection will commence at 0800 on Monday 16th

February); the final patient reaching 30-day follow up on Thursday 2nd April.

DATA COLLECTION

Data is to be recorded on eligible patients during three stages:

Preoperatively up to the point of leaving recovery.

48 hours after leaving recovery.

30 days after the day of surgery

To achieve the studies objectives and determine whether audit standards are being met, the data

collection form has been divided into sections (see Data collection form Appendix 1). The data

collected during each section is summarised below with definitions being found in the guidance

notes (Appendix 2):

Demographic data

Preoperative data

Type of surgery and level of urgency

Regular pre-operative analgesia and relevant medical history.

Analgesic Approach

Premed analgesia

Intra-operative analgesia

Post operative analgesic plan

Recovery data

9


Analgesic failure in theatre recovery

Efficacy of pain management prior to leaving recovery

48 hours after leaving recovery

Occurrence of moderate or severe pain over the first 48 hours following surgery.

Unplanned changes to analgesic modality

Involvement of an Acute Pain Service

30 days following surgery

Length of stay (in days)

All cause Emergency Department attendance following discharge up to 30 days

All cause 30 day readmission

Surgical complications at 30 days (Clavien Dindo)

Data will be collected locally on a paper data collection form (Appendix 1) with collected data

subsequently being entered onto an excel spreadsheet. Data on completed spreadsheets will be

anonoymised and collated centrally using nhs email encrypted accounts. Patient anonymised data

will then be analysed and reported by the studies steering committee. Anonymised hospital data will

be compared, but individual surgeons, hospitals or NHS trusts will not be identified in the reporting

of this study.

The successful delivery of this audit requires collaboration between surgical, anaesthetic and pain

management teams to ensure all data is collected accurately for the duration of the study. Local

arrangements for collection of this data may vary, but allocation of responsibility for each section

must be clarified with all individuals taking part prior to commencement of data collection.

Data collection points:

Each trust/hospital site will need to identify locations where open or laparoscopic abdominal

surgical procedures (not day case) are performed to ensure full capture of cases during the

audit period.

Patient identification: Patients should be identified on a daily basis from the elective and

emergency operative lists and booking lists, assisted by the on-call teams.

10


Preoperative data: This will be completed from information collected from the anaesthetic

chart or patients’ medical record.

Operative surgical data: This should be completed either by, or with input from, the

operating surgeon or assistant.

Perioperative pain management data: This should be completed from information on the

anaesthetic record and the postoperative (recovery/PACU) care plan.

Postoperative data (inpatient): This should be completed from information from the patient

observation charts (paper or electronic) and clinical notes.

Postoperative data (30 day follow up): All patients will be followed up for 30 days following

their operation. The hospital’s electronic or paper records should be checked by the team to

identify readmissions or reattendances to either the hospital’s Emergency Department,

surgical assessment unit, medical assessment unit, or wards.

Authorship

Preparation of the manuscript for publication will be by performed by a writing committee.

Collaborators (maximum 6 per hospital including supervising consultant) contributing to the

running of the study and data collection will be eligible to be listed as ‘Pubmed’ citable

authors. In return, each collaborating team should participate in the creating of the local

system, registering the study with the audit department, identifying patients, collecting data

and completing 30-day follow-up.

The supervising consultant(s) will have to oversee validity by ensuring a complete, accurate

dataset is returned

Units who fail to submit data will be excluded from the authorship list

If substantially incomplete data is submitted the writing committee may decide to exclude

that unit from further analysis and subsequently remove collaborators from the authorship

list.

11


Appendix 1- Data collection form

Demographic data

Hospital Number: _________ Age (yrs): ____ Gender: Male □ Female □

Admission Date: __ /__ /__ Operation Date: __ /__ /__ ASA:____

Pre-operative data

1. Body mass index (BMI): <18.0 □ 18.0 – 24.99 □ 25.0 – 29.99 □

30.0-34.99 □ 35.0 - 39.99 □ ≥ 40.0 □

2. Regular Pre-operative Analgesia None □ Paracetamol □ NSAID □ (tick all that apply): Weak Opioid □ Strong Opioid □

Anticonvulsant □ Antidepressant □Other _____________

3. Current medical history: Epilepsy □ Depression/anxiety requiring medication □ Chronic pain clinic attendance in the last year □ None of Above □

4. Surgery: a. Elective □ Emergency □

b. Laparoscopic □ Open □ Lap converted □Hybrid procedure □

c. Upper GI □ Hepatobiliary □ Colorectal □Vascular □Other ____________________________________

d. Resection Yes □ No □ For confirmed malignancy Yes □ No □

12


Analgesic Approach5. Analgesic Pre-med administered: None □ Paracetamol □ NSAID □

(tick all that apply) Weak Opioid □ Strong Opioid □ Anticonvulsant □ Antidepressant □Other _____________

6. Intra-operative analgesia (tick all that apply):

Epidural local anaesthetic □ Spinal local anaesthetic □ Intrathecal/epidural opiate □ Continuous opioid intravenous Infusion □ Regional catheter block □ Regional single shot block □LA to wound □ Paracetamol □ NSAID □ Weak opioid □ Strong opioid □ None □ Other___________________

7. Post-op analgesic plan (tick all that apply)

Epidural □ Spinal block □ Regional catheter block □ Regional single shot block □ LA to wound □ Paracetamol □ NSAID □ Weak opiate □ Strong opioid (not inc IV infusion/PCA) □ Continuous intravenous opioid Infusion □ Patient controlled opioid Infusion (PCA) □ None □ Other__________________________

Recovery data

8. In recovery: unplanned change to analgesia?

None □ Conversion of regional analgesic technique to other modality □ Additional opioid prescribed and administered □ Other __________________________________________

9. Last pain score (see guidance notes) prior to leaving recovery

At rest: Unclear □ None □ Mild □ Moderate □ Severe □

On movement: Unclear □ None □ Mild □ Moderate □ Severe □

If "Unclear" whether at rest or on movement (e.g. only one pain score recorded) document recording here:

None □ Mild □ Moderate □ Severe □

13


48hrs after leaving recovery

10. Recorded incidence of moderate or severe pain in first 24 hours after leaving recovery:

Yes □ No □ (If "No" go to Q11)

a IF YES; Two consecutive occurrences of moderate or severe pain in first 24 hours after leaving recovery:

Yes □ No □

11. Occurrence of moderate or severe pain between 24 and 48 hours after leaving recovery:


a. IF YES; Two consecutive occurrences of moderate or severe pain between 24 and 48 hours after leaving recovery:

Yes □ No □

12. Was the patient reviewed by an anaesthetist or the acute pain service within 48 hours of the patient leaving recovery ?


If YES; Was the review planned or unplanned?

Planned □ Unplanned □

13. Was an unplanned change to analgesic modality made during the 48 hours after the patient left recovery?

None □ Conversion of regional analgesic technique to other modality □ Additional opioid prescribed and administered □ Other __________________________________________

14. Was the patient in ITU or HDU for the entire 48 hours after leaving recovery?

Yes □ No □

14


Section 6: 30 days after surgery

15. Date of discharge or death: __ /__ /__ (dd/mm/yyyy)

(Tick box if still inpatient at 30 days □ and then go to Q19)

16. Prescription of the following at discharge (in TTOs):

Strong opioids □ Anticonvulsants □ Antidepressants □

None of Above □

17. All-cause 30-day A&E attendance Yes □ No □

18. All-cause 30-day readmission Yes □ No □

19. Have unplanned antibiotics been administered for hospital acquired chest infection/pneumonia.

Yes □ No □

20. Surgical Complications at 30 days (Clavien-Dindo-record highest only- see guidelines):

None □

Grade 1 Deviation from normal postoperative course □

Grade 2 Requiring pharmacological treatment (e.g. Unplanned antibiotics) □

Grade 3 Surgical, endoscopic or radiological intervention

3a- NOT requiring GA □

3b- Requiring GA □

Grade 4 Life-threatening complication requiring IC/ICU admission

4a- Single organ dysfunction □

CVS □ Respiratory □ Renal □ Other □

4b- Multiorgan dysfunction □

Grade 5 Death □

Cause of Death 1a).............................................

15


Appendix 2- Guidance Notes1. BMI = mass [kg] / (height [m])2

2,5,6,7&16. NSAID e.g. Ibuprofen, Diclofenac, Naproxen and Aspirin IF >75mg/day

Weak Opioid e.g. Codeine, Dihydrocodeine, Meptazinol Strong Opioid e.g. Morphine Sulphate (any preparation),

Tramadol, Tapentadol, Pethidine, Fentanyl, Alfentanil, Remifentanil, Oxycodone, Methadone, Diamorphine, Buprenorphine

Anticonvulsant e.g. Gabapentin, PregabalinAntidepressant e.g. Amitriptyline

3. Please record only epilepsy, depression/ anxiety that is being treated/controlled with medication at the time of surgery.

4a. Elective Operation performed following a planned admission.Emergency Operation performed following an unplanned admission.

4b. Laparoscopic Operation performed using laparoscopic techniques. Includes bowel resections in which an open incision is made to remove specimen.

Open Operation performed via an open abdominal incision without laparoscopy.

Lap Converted Operation attempted laparoscopically but completed via an open abdominal incision.

Hybrid procedure Operation in which both laparoscopic and open surgical

techniques are intentionally used to perform an operation e.g. 2 stage oesophagectomy in which abdominal stage is performed laparoscopically and thoracic stage via an open thoracotomy.

4c. Upper GI e.g. anti-reflux surgery, bariatric procedures, oesophagogastric cancer resections, perforated peptic ulcer, splenectomy, laparotomy for gastric, duodenal or splenic trauma.

Hepatobiliary e.g. cholecystectomy, liver resection,

pancreaticoduodenectomy, laparotomy for liver trauma.

Colorectal e.g. colectomy/ large or small bowel resection (including appendicectomy), inflammatory bowel surgery. Laparotomy for adhesions, obstruction or bowel trauma.

16


4d. Resection e.g. of large or small bowel (including appendix), gallbladder, liver or spleen.

Malignancy For confirmed malignancy either histologically or radiologically.

5. Analgesic pre-med- an analgesic specifically prescribed by an anaesthetist and is administered as part of perioperative pain management.See Q2 notes above.

6&7. See Q2 notes above. For a spinal block containing both bupivicaine and fentanyl, tick both spinal

local anaesthetic and intrathecal opioid.Continuous opioid IV Infusion e.g. Remifentanil, AlfentanilRegional catheter block e.g Transversus Abdominis plane (TAP) infusionRegional single shot block e.g. Transversus Abdominis Plane (TAP) block

8/13. Conversion of regional analgesic technique to other modality e.g. switching an epidural to morphine PCAAdditional opioid prescribed and administered e.g. additional IV morphine

Pain Scores: These will depend on the scale used routinely by your trust. The commonest are 0-3 or 0-10. The 0-3 scale may appear similar to this:

17


The 0-10 scale may appear similar to this:

No pain is defined as 0/3 on 0-3 scale and 0 on the 0-10 scale.

Mild pain is defined as 1/3 on the 0-3 scale and 1-3 on the 0-10 scale.

Moderate pain is defined as 2/3 on 0-3 scale and 4-6 on the 0-10 scale.

Severe pain is defined as 3/3 on 0-3 scale and 7-10 on the 0-10 scale.

9. Last pain score Last recorded pain score prior to leaving recovery. Please record "Unclear" if it is unclear whether the score is at

rest or on movement and record separately if only one pain score is recorded.

10. Occurrence of moderate or severe pain in first 24 hours after leaving recovery

Moderate pain is defined as 2/3 on 0-3 scale and 4-6 on the 0-10 scale.Severe pain is defined as 3/3 on 0-3 scale and 7-10 on the 0-10 scale.

N.B. If patient leaves recovery at 3pm then the first 24 hours will be until and including 3pm the following day.

11. Occurrence of moderate or severe pain between 24 and 48 hours after leaving recovery.Moderate and severe pain defined as for Q9&10 above but between 24 and 48 hours after leaving recovery.

11a. Two consecutive occurrences of moderate or severe pain between 24 and 48 hours after leaving recovery:Should include last recorded pain score in first 24hours and first pain score between 24 and 48 hours. e.g. If the last pain score recorded in the first 24 hours is 2/3 or 5/10 and the first pain score recorded during the next 24hours is 2/3 or 4/10 then YES two consecutive occurrences of moderate pain have occurred between 24 and 48 hours.

18


12. Acute Pain service. Selecting "Yes" indicates a patient was seen by an anaesthetist and/or an Acute pain team within 48 hours of leaving recovery to review the patients pain management.

12a. If "YES" to Q12 Planned or Unplanned?Selecting "Yes" indicates for the type of operation or for the type of postoperative analgesia regime that an Acutepain team and/or anaesthetist routinely would review the patient postoperatively or that for this particular patient a pain team review was planned to occur within 48 hrs of the patient leaving recovery.

13. See Q8 notes above.

16. See Q2 notes.

17. Record any Accident and Emergency attendances up to 30 days following surgery.

18. Readmission is defined as any further admission following discharge which requires an overnight stay. The date of readmission must be within 30 days of surgery.

20.Clavien Dindo Classification (defined by treatment required and the highest grade of complication experienced by a patient is recorded)Grade 1 Any deviation from the normal postoperative course without the

need for pharmacological treatment or surgical, endoscopic or radiological interventions. Allowed therapeutic regimes are: drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.

Grade 2 Requiring pharmacological treatment with drugs other than such allowed for grade 1 complications. Blood transfusions and total parenteral nutrition are also included.

Grade 3 Requiring surgical, radiological or endoscopic intervention.3a: Intervention not under general anaesthesia3b: Intervention under general anaesthesia

Grade 4 Life-threatening complication (including central nervous system complication) requiring Intensive Care/High Dependency (Level 2/3) management4a: Single organ dysfunction (including dialysis/renal replacement therapy)4b: Multi-organ dysfunction

Grade 5 Death of a patient

19

wmresearch.org.ukwmresearch.org.uk/wordpress/wp-content/uploads/2014… · web viewupper gie.g....

Documents