EPAS: Epidural versus Picra for Abdominal Surgery

ISRCTN	ISRCTN18637372
DOI	https://doi.org/10.1186/ISRCTN18637372
Protocol serial number	H07-02916
Sponsor	University of British Columbia (Canada)
Funder	Investigator initiated and funded (Canada) - no external funding will be sought

Submission date: 19/12/2007
Registration date: 10/12/2008
Last edited: 10/12/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Charles Scudamore
Scientific

Gordon & Leslie Diamond Health Care Center
5th floor 2775 Laurel Street
Vancouver
V5Z 1M9
Canada

Study information

Primary study design	Interventional
Study design	Randomised, prospective controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Comparison of epidural catheters versus surgical wound catheters for analgesia after major hepatobiliary and pancreatic surgeries
Study acronym	EPAS
Study objectives	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(s)	Ethics approval pending as of 19/12/2007 from: 1. University of British Columbia 2. Vancouver Coastal Health
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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
Key exclusion criteria	Does not meet the inclusion criteria
Date of first enrolment	01/02/2008
Date of final enrolment	01/02/2008

Locations

Countries of recruitment

Canada

Study participating centre

Gordon & Leslie Diamond Health Care Center

Vancouver
V5Z 1M9
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan