Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
At St James's University Hospital, the standard practice for analgesia (pain relief) after abdominal surgery is to use epidural catheters, which involves injecting anaesthetic through a catheter (tube) into a space inside the spine. The aim of this study is to compare this well known technique with wound catheters plus patient-controlled analgesia (PCA), where the patient administers their own pain relief.

Who can participate?
Adults scheduled to have liver surgery

What does the study involve?
Patients are randomly allocated to one of two treatments: wound catheters for continuous infusion of local anaesthetic and PCA with opioids, or epidural catheters (standard of care). The care received after surgery is exactly the same with the exception of pain control in the initial 72 hours after surgery. Length of stay is measured from surgery to becoming medically fit for discharge.

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?
St James's University Hospital (UK)

When is the study starting and how long is it expected to run for?
April 2015 to December 2017

Who is funding the study?
Investigator initiated and funded (UK)

Who is the main contact?
Mr Ernest Hidalgo

Trial website

Contact information



Primary contact

Mr Ernest Hidalgo


Contact details

St James's University Hospital
ICU Offices
Bexley Wing
3rd Floor
United Kingdom
+44 (0)113 206 4887

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


Study hypothesis

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.

Ethics approval

National Research Ethics Service Committee Yorkshire and Humber - Bradford Leeds, 05/12/2014, ref: 14/YH/1267

Study design

Open-label randomised control trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a 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)

Intervention type



Drug names

Primary outcome measure

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


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Age >18 years old
2. Scheduled to undergo an open liver resection

Participant type


Age group




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
5. Pregnancy
6. Lactation
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

United Kingdom

Trial participating centre

St James's University Hospital
Bexley Wing 3rd Floor
United Kingdom

Sponsor information


Leeds Teaching Hospitals NHS Trust

Sponsor details

34 Hyde Terrace
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Investigator initiated and funded

Alternative name(s)

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, the aim is to produce a manuscript for publication as well as in-house and appropriate conference presentations

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Mr Ernest Hidalgo (

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

See additional file (ISRCTN16447784_BasicResults_18Dec18.pdf).

Publication list

Publication citations

Additional files

Editorial Notes

18/12/2018: The basic results of this trial have been uploaded as an additional file. 26/01/2018: The recruitment end date was changed from 01/09/2017 to 01/10/2017. 08/03/2017: The following changes were made to the trial record: 1. The recruitment end date was changed from 01/09/2016 to 01/09/2017. 2. The overall trial end date was changed from 01/10/2016 to 01/12/2017.