Additional identifiers
EudraCT number
2009-014375-50
ClinicalTrials.gov number
Protocol/serial number
1.7
Study information
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)
Acronym
E-WIC
Study hypothesis
Wound infusion catheter is at least as effective as epidural following laparoscopic colectomy within the Enhanced Recovery Programme.
Ethics approval
South West Research Ethics Committee, 01/02/2010, ref: 09/H0206/66
Study design
Pilot randomised controlled 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 below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
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.
Secondary outcome measures
1. Rescue analgesia. Analgesia log will be filled in daily by research nurse
2. Patient reported outcomes will be recorded pre operatively as baseline and prior to discharge by the research nurse using a structured questionnaire
3. Quality of life assessment using SF-36® Health Survey and Euroqol EQ-5D at baseline, prior to discharge and at two week follow up
4. A subset of 10 patients will be invited to take part in video recorded interviews at two week follow up to assess the success of blinding and to investigate the patient experience of taking part
5. Complications will be entered into a data sheet at discharge by the research fellow and followed up to 30 days to capture readmission, morbidity and mortality
6. Length of hospital stay will be recorded by the research nurse at discharge
7. Standard performance indicators using short physical performance battery will be assessed by the research nurse at baseline and 48 hours post operatively
8. Stress response to surgery and the effect of analgesic method will be investigated with blood samples taken at baseline, 3, 6, 12 and 24 hours after surgery. This will be performed by the research fellow or on call doctor to a strict protocol. The samples will measure epinephrine, cortisol, insulin and interleukin-6.
Overall trial start date
29/11/2009
Overall trial end date
07/02/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant 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
Recruitment start date
01/04/2010
Recruitment end date
01/04/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Yeovil District Hospital
Yeovil
BA21 4AT
United Kingdom
Sponsor information
Organisation
Yeovil District Hospital NHS Foundation Trust (UK)
Sponsor details
Yeovil District Hospital
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23254324