Condition category
Surgery
Date applied
03/02/2015
Date assigned
13/04/2015
Last edited
13/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
ernest.hidalgo@nhs.net

Trial website

Contact information

Type

Public

Primary contact

Mr Ernest Hidalgo

ORCID ID

http://orcid.org/0000-0002-4680-9580

Contact details

St James's University Hospital
ICU Offices
Bexley Wing
3rd Floor
Leeds
LS9 7TF
United Kingdom
+4401132064887
ernest.hidalgo@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RL14/11048

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

Acronym

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, approval number 14/YH/1267

Study design

Open- label randomised control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Postoperative pain control and recovery after surgery

Intervention

1. Wound catheters for continuous infusion of local anaesthesia, along with intravenous PCA with morphine
2. Epidural catheters (standard of care)

Intervention type

Procedure/Surgery

Phase

Drug names

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

01/04/2015

Overall trial end date

01/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

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

15/03/2015

Recruitment end date

01/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St James's University Hospital
Bexley wing 3rd floor
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Leeds Teaching Hospitals NHS Trust

Sponsor details

34 Hyde Terrace
Leeds
LS2 9LN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

28/02/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes