Epidural versus Wound Infusion Catheter Study
| ISRCTN | ISRCTN27347736 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27347736 |
| Clinical Trials Information System (CTIS) | 2009-014375-50 |
| Protocol serial number | 1.7 |
| Sponsor | Yeovil District Hospital NHS Foundation Trust (UK) |
| Funder | National Institute for Health Research |
- Submission date
- 07/09/2009
- Registration date
- 28/10/2009
- Last edited
- 27/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Yeovil District Hospital
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Comparison of the efficacy of thoracic Epidural analgesia and a local anaesthetic Wound Infusion Catheter after laparoscopic colectomy within the Enhanced Recovery Programme: a pilot randomised controlled trial (RCT) |
| Study acronym | E-WIC |
| Study objectives | Wound infusion catheter is at least as effective as epidural following laparoscopic colectomy within the Enhanced Recovery Programme. |
| Ethics approval(s) | South West Research Ethics Committee, 01/02/2010, ref: 09/H0206/66 |
| Health condition(s) or problem(s) studied | Laparoscopic colectomy within an enhanced recovery programme |
| Intervention | Patients recruited from colorectal outpatient clinic will be randomised to receive either epidural or wound infusion catheter. |
| Intervention type | Other |
| Primary outcome measure(s) |
Patient reported pain assessment. This will be assessed at baseline before the operation, on return to the ward after surgery and twice daily at 10.00 and 16.00 on days one and two post operatively. It will then be measured once daily until discharge and in outpatient follow up two weeks post operation. |
| Key secondary outcome measure(s) |
1. Rescue analgesia. Analgesia log will be filled in daily by research nurse |
| Completion date | 07/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Both males and females, aged 18 or over 2. Patients undergoing elective laparoscopic colectomy for right or left sided benign or malignant tumour of the colon, with intention to cure 3. American Society of Anesthesiology score of I, II or III 4. Able to provide written informed consent |
| Key exclusion criteria | 1. Transverse colon or rectal tumour 2. Locally advanced (T4) or widespread distant disease. Palpable mass. 3. Emergency admission or obstruction/perforated disease 4. Inflammatory bowel disease (Crohn's Disease or Ulcerative Colitis) 5. Known allergy to local anaesthetic 6. Multiple sclerosis or chronic pain requiring regular strong opiate drugs 7. Recent history of drug or alcohol abuse 8. Contraindication to epidural 9. Poor cognitive ability making consent or completion of questionnaires impossible 10. Pregnant women |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 01/04/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
BA21 4AT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2013 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/11/2015: Publication reference added.