ISRCTN ISRCTN18637372
DOI https://doi.org/10.1186/ISRCTN18637372
Secondary identifying numbers H07-02916
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

Study designRandomised, prospective controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleComparison of epidural catheters versus surgical wound catheters for analgesia after major hepatobiliary and pancreatic surgeries
Study acronymEPAS
Study objectivesWe 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) studiedMajor hepatobiliary and pancreatic surgeries
InterventionEpidural 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 typeProcedure/Surgery
Primary outcome measureThe 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 measures1. 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 study start date01/02/2008
Completion date01/02/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100
Key inclusion criteriaPatients 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 criteriaDoes not meet the inclusion criteria
Date of first enrolment01/02/2008
Date of final enrolment01/02/2008

Locations

Countries of recruitment

  • Canada

Study participating centre

Gordon & Leslie Diamond Health Care Center
Vancouver
V5Z 1M9
Canada

Sponsor information

University of British Columbia (Canada)
University/education

Department of Surgery
Faculty of Medicine
3100, 910 West 10th Avenue
Vancouver
V5Z 4E3
Canada

Website http://www.ubc.ca/
ROR logo "ROR" https://ror.org/03rmrcq20

Funders

Funder type

Other

Investigator initiated and funded (Canada) - no external funding will be sought

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan