Epidural versus Wound Infusion Catheter Study

ISRCTN	ISRCTN27347736
DOI	https://doi.org/10.1186/ISRCTN27347736
EudraCT/CTIS number	2009-014375-50
Secondary identifying numbers	1.7

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Nader Francis
Scientific

Yeovil District Hospital
Higher Kingston
Yeovil
BA21 4AT
United Kingdom

Study information

Study design	Pilot randomised controlled 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 below to request a patient 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	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 study start date	29/11/2009
Completion date	07/02/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Yeovil District Hospital

Yeovil
BA21 4AT
United Kingdom

Sponsor information

Yeovil District Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

Yeovil District Hospital
Higher Kingston
Yeovil
BA21 4AT
England
United Kingdom

Website	http://www.yeovilhospital.nhs.uk/
"ROR"	https://ror.org/00v5nyn36

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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

Editorial Notes

27/11/2015: Publication reference added.