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:

Charlotte Small, Research Fellow in Anaesthesia and Critical Care

Email:

Version No 1.4

Date: 10/11/2014

KEY CONTACTS

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

Email:

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

Email:

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

Email:

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

Email:

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

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
(
Chief Investigators / Paul Marriott/Charlotte Small
Website /
Email /
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 ClavienDindo 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

Across the UK there is widespread variability in the approaches used to manage pain in patientsundergoingsurgery. Nevertheless goodperioperative analgesia is essential to optimise patient outcomes.

This study aims to describe current practice in perioperative pain management following abdominal surgeryand to observe how pain control affects post-operative outcomes.

Data will be collected over two weeks using a multi-centre prospective observationaldesign. 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 andResults of a Survey Ann Surg.; 244: 931-937

INTRODUCTION

Across the UK there is widespread variability in the approaches to management of perioperative analgesia in patientsundergoingabdominalsurgery. 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 unprovenwhat 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 futureprospective studies of analgesicregimes, novel approaches or agents that may improve patient outcomes, it is necessary to understand how effective currentperi-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.

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 patientsis 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 inperioperative 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 projectsbetween the rapidly evolving trainee research networks in surgery and anaesthesia in the UK (Bhangu et al., 2013).

6.0 DESIGN AND METHODS

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

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.

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 thedata 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.

The pilot has also demonstrated over a 2 week period,data on approximately 30-70patients could be collected per site. Previous studies conducted by the West Midlands, Nationaland Medical student collaborativeshave 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 formAppendix 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

  • 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 (ClavienDindo)

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.
  • 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 bythe 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 datawill 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.

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 requiringmedication □ Chronic pain clinic attendancein 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.ResectionYes □ No □

For confirmed malignancy Yes □ No □

Analgesic Approach

5.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 □

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)

aIF 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 afterleaving recovery:

Yes □ No □ (If "No" go to Q12)

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 ?

Yes □ No □ (If "No" go to Q13)

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 □

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):