Plain English Summary
Background and study aims
In our centre, the standard practice for analgesia (pain relief) following abdominal surgery is use of epidural catheters. We aim to compare this well known technique with wound catheters plus PCA.
Who can participate?
Adults scheduled to have liver surgery
What does the study involve?
Patients will be randomly allocated to one of two treatments: wound catheters for continuous infusion of local anaesthesia and PCA with opioids or epidural catheters (standard of care). The care received after surgery will be exactly the same with the exception of pain control in the initial 72 hours after surgery.
What are the possible benefits and risks of participating?
A potential benefit is shorter recovery. Risks are related to the insertion of the wound catheters only.
Where is the study run from?
Saint James's University Hospital (UK)
When is the study starting and how long is it expected to run for?
From April 2015 to October 2016
Who is funding the study?
Investigator initiated and funded (UK)
Who is the main contact?
Mr Ernest Hidalgo
Comparison of epidural analgesia and patient-controlled continuous local anaesthetic infusion via a wound catheter for pain control after open liver resection: an open-label randomised controlled trial
1. Pain relieve with continuous preoperative infusion of local anaesthetic via wound catheters will minimise the use of patient-controlled analgesia (PCA) with intravenous opioids and will be similar to epidural analgesia.
2. Without epidural analgesia, recovery following surgery will be optimised with a shorter postoperative stay.
National Research Ethics Service Committee Yorkshire and Humber - Bradford Leeds, 05/12/2014, approval number 14/YH/1267
Open- label randomised control trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Postoperative pain control and recovery after surgery
1. Wound catheters for continuous infusion of local anaesthesia, along with intravenous PCA with morphine
2. Epidural catheters (standard of care)
Primary outcome measures
Length of stay from surgery to becoming medically fit for discharge, measured in days
Secondary outcome measures
1. Time in theatre
1.1. Anaesthetic time (anaesthetic room to incision)
1.2. Surgical time (incision to completion of closure, including the insertion of wound catheters)
2. Pain scores, estimated with Painmatcher® in addition to visual analogue scale everyday until discharge
3. Length of stay in high dependency unit (days)
4. Peak flow measurements at baseline and day 1 to day 5
5. Total volume (mL) of intravenous fluid required in theatre and every 24 hours
6. Total need for vasopressors
7. Total daily opioid analgesia (conversion to morphine mg equivalent) required everyday until discharge
8. Time to first bowel movement (days)
9. Nausea, on a scale of 1–3 on days 1, 2 and 3
10. Sedation, on a scale of 1–3 on days 1, 2 and 3
11. Mobility: time to first sitting in chair (hours)
12. Incidence of complications (related to surgery and analgesia), up to discharge
13. Patient satisfaction (EQ-5D questionnaire)
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Age >18 years old
2. Scheduled to undergo an open liver resection
Target number of participants
80 (powered to 80% with p<0.05): 40 per arm
Participant exclusion criteria
1. Contraindications to epidural
2. Inability to consent
3. Age < 18 years old
4. Liver resection combined with a second procedure
7. History of chronic pain
8. Body-mass index <18 kg/m2 or >40 kg/m2
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
St James's University Hospital
Bexley wing 3rd floor
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
1. The study will be audited at 6 months and 12 months after it starts; a data reviewing committee will be established to oversee the results.
2. Following termination of recruitment and data analysis, we aim to produce a manuscript for publication as well as in-house and appropriate conference presentations.
3. Publish final results in 2 years
Intention to publish date
Participant level data
Available on request
Results - basic reporting