Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
H07-02916
Study information
Scientific title
Comparison of epidural catheters versus surgical wound catheters for analgesia after major hepatobiliary and pancreatic surgeries
Acronym
EPAS
Study hypothesis
We hypothesise that surgical wound catheters with patient controlled anaesthesia are equivalent to epidural catheters with patient controlled anaesthesia with respect to post-operative pain, complications and return to function.
Ethics approval
Ethics approval pending as of 19/12/2007 from:
1. University of British Columbia
2. Vancouver Coastal Health
Study design
Randomised, prospective controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Major hepatobiliary and pancreatic surgeries
Intervention
Epidural catheters and surgical wound catheters.
On the day of surgery, the patient will be randomised to either the epidural or wound catheter. The wound catheter will be placed by the attending surgeon at the end of the procedure, while the epidural will be placed by the anaesthesiologist at the beginning of the procedure. Both groups will also be equipped with patient controlled analgesia (PCA). Our Post-operative Pain Service (POPS) will monitor the pain control of these patients and make adjustments regarding the rate of infusion of both these devices. The removal of the devices will be left at the discretion of the attending anaesthesiologist on POPS, which generally is between 2 - 5 days. The duration of follow up and the intervention will be the length of the patient's inpatient stay, which is obviously individualised for each patient.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
The total amount of analgesic used as determined by the patient controlled anaesthesia pump. This will be assessed via each patient's post-operative anaglesia sheet, which is a common method in our hospital, commonly used by our nursing staff.
Secondary outcome measures
1. The subjective scores of the post-operative pain, monitored via a Visual Analogue Scale (1 - 10) twice daily (BID)
2. Total time requiring the epidural or wound catheter
3. Total length of hospitalisation
4. Level of ambulation and activity, recorded by nursing staff on analgesic sheets
5. Time for return of full diet, recorded by nursing staff on analgesic sheets
6. Time for return of full gastrointestinal function, recorded by nursing staff on analgesic sheets
Overall trial start date
01/02/2008
Overall trial end date
01/02/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients will be eligible to be enrolled in the study only after each of the following criteria are met:
1. Aged greater than or equal to 18 years, either sex
2. Cheyne abdominal incision used
3. Pre-operative International Normalised Ratio (INR) less than or equal to 1.3
4. Pre-operative platelet count greater than or equal to 100,000/uL
5. No prior epigastric incision
6. Body mass index (BMI) less than 30 kg/m^2
7. No signs of systemic sepsis
8. No allergies to agents or medications
9. Willingness to accept either surgical wound catheter or epidural catheters
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
Does not meet the inclusion criteria
Recruitment start date
01/02/2008
Recruitment end date
01/02/2008
Locations
Countries of recruitment
Canada
Trial participating centre
Gordon & Leslie Diamond Health Care Center
Vancouver
V5Z 1M9
Canada
Sponsor information
Organisation
University of British Columbia (Canada)
Sponsor details
Department of Surgery
Faculty of Medicine
3100
910 West 10th Avenue
Vancouver
V5Z 4E3
Canada
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Canada) - no external funding will be sought
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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