EPAS: Epidural versus Picra for Abdominal Surgery
ISRCTN | ISRCTN18637372 |
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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
Scientific
Gordon & Leslie Diamond Health Care Center
5th floor 2775 Laurel Street
Vancouver
V5Z 1M9
Canada
Study information
Study design | Randomised, prospective controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 01/02/2008 |
Completion date | 01/02/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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
V5Z 1M9
Canada
Sponsor information
University of British Columbia (Canada)
University/education
University/education
Department of Surgery
Faculty of Medicine
3100, 910 West 10th Avenue
Vancouver
V5Z 4E3
Canada
Website | http://www.ubc.ca/ |
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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 | |
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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 |