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
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
+44 (0)113 206 4887
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, ref: 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
Not available in web format, please use the contact details to request a 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 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
01/04/2015
Overall trial end date
01/12/2017
Reason abandoned (if study stopped)
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
01/10/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St James's University Hospital
Bexley Wing
3rd Floor
Leeds
LS9 7TF
United Kingdom
Funders
Funder type
Other
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, 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 (ernest.hidalgo@nhs.net).
Intention to publish date
01/12/2017
Participant level data
Available on request
Basic results (scientific)
See additional file (ISRCTN16447784_BasicResults_18Dec18.pdf).
Publication list
Publication citations
Additional files
- ISRCTN16447784_BasicResults_18Dec18.pdf Uploaded 18/12/2018