Comparison of epidural catheters and wound catheters for pain control after liver surgery
| ISRCTN | ISRCTN16447784 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16447784 |
| Secondary identifying numbers | RL14/11048 |
- Submission date
- 03/02/2015
- Registration date
- 13/04/2015
- Last edited
- 18/12/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Public
St James's University Hospital
ICU Offices
Bexley Wing
3rd Floor
Leeds
LS9 7TF
United Kingdom
 ORCID ID |
0000-0002-4680-9580 |
|---|---|
| Phone | +44 (0)113 206 4887 |
| ernest.hidalgo@nhs.net |
Study information
| Study design | Open-label randomised control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 objectives | 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(s) | National Research Ethics Service Committee Yorkshire and Humber - Bradford Leeds, 05/12/2014, ref: 14/YH/1267 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2015 |
| Completion date | 01/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 (powered to 80% with p<0.05): 40 per arm |
| Key inclusion criteria | 1. Age >18 years old 2. Scheduled to undergo an open liver resection |
| Key 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 |
| Date of first enrolment | 15/03/2015 |
| Date of final enrolment | 01/10/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
3rd Floor
Leeds
LS9 7TF
United Kingdom
Sponsor information
Hospital/treatment centre
34 Hyde Terrace
Leeds
LS2 9LN
England
United Kingdom
"ROR" |
https://ror.org/00v4dac24 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 18/12/2018 | 18/12/2018 | No | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN16447784_BasicResults_18Dec18.pdf
- Uploaded 18/12/2018
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.
