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 RCT - Epidural vs Wound Infusion Catheter (E-WIC) v1.0

• Conditions: Patients undergoing elective laparoscopic colectomy for either benign or malignant tumour in the right or left colon with intention to cure.; MedDRA version: 12Level: LLTClassification code 10009944Term: colon cancer; MedDRA version: 12Level: LLTClassification code 10009946Term: Colon Cancer Duke's A; MedDRA version: 12Level: LLTClassification code 10009947Term: Colon Cancer Duke's B1; MedDRA version: 12Level: LLTClassification code 10009948Term: Colon Cancer Duke's B2; MedDRA version: 12Level: LLTClassification code 10009949Term: Colon Cancer Duke's C; MedDRA version: 12Level: LLTClassification code 10009952Term: Colon Cancer Recurrent; MedDRA version: 12Level: LLTClassification code 10009953Term: Colon Cancer Stage I; MedDRA version: 12Level: LLTClassification code 10009954Term: Colon Cancer Stage II; MedDRA version: 12Level: LLTClassification code 10009955Term: Colon Cancer Stage III

• Registration Number: EUCTR2009-014375-50-GB
• Lead Sponsor: Yeovil District Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients undergoing elective laparoscopic colectomy for either benign or malignant tumour in the right, left or transverse colon with intention to cure.
2. Aged 18 or over with Americal Society of Anaesthesiology (ASA) score I, II or III.
3. Able and willing to provide written consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Transverse colon or rectal tumour.
2. Locally advanced or widespread disease - stage T4 on CT scan - palpable mass or distant metastasis.
3. Emergency admission or obstruction/perforation of bowel cancer.
4. Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis).
5. Known allergy to local anaesthetic.
6. Multiple Sclerosis or chronic pain requiring regular strong opioid analgesia.
7. Recent history of alcohol or drug abuse.
8. Contraindication to epidural analgesia.
9. Poor cognitive ability.
10. Pregnant patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This pilot aims to test the feasibility of a large Randomised Control Trial (RCT). The full RCT is to compare the effectiveness of wound infusion catheter (WIC) and standard epidural analgesia following laparoscopic colectomy (key hole surgery to remove part of the large bowel) within an Enhanced Recovery Programme. The pilot will provide information on rates of recruitment, data collection and descriptive information on the outcome measures to aid power calculations (which tell us how many patients will be needed in the full RCT). It will also test the ability to successfully blind patients and research personnel to group allocation. This means that they will not know which treatment they are having, and hleps prevent the results from being biased.;Secondary Objective: ;Primary end point(s): Patient reported pain assessment as measured by the Memorial Pain Assessment Card at intervals throughout the patient stay.