Condition category
Surgery
Date applied
19/12/2007
Date assigned
10/12/2008
Last edited
10/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charles Scudamore

ORCID ID

Contact details

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

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 measures

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

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

http://www.ubc.ca/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes