Effect of pregabalin in acute post-operative pain and functional recovery for laparoscopic cholecystectomy
| ISRCTN | ISRCTN01000893 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01000893 |
| Protocol serial number | N/A |
| Sponsor | Pfizer (Canada) |
| Funder | Support from Department of Anesthesiology and Pain Management, University of Toronto (Canada) |
- Submission date
- 03/01/2007
- Registration date
- 13/02/2007
- Last edited
- 26/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
McL 2-405
Toronto Western Hospital
399 Bathurst Street
Toronto
M5T 2S8
Canada
| Phone | +1 (1)416 603 5118 |
|---|---|
| philip.peng@uhn.on.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind, randomised, controlled study |
| Secondary study design | Randomised controlled trial |
| Scientific title | Effect of pregabalin in acute post-operative pain and functional recovery for laparoscopic cholecystectomy |
| Study objectives | Pregabalin provides superior post-operative pain control, lower analgesic consumption and better recovery profile compared with placebo. |
| Ethics approval(s) | Approval received from the University Health Network Research Ethic Board, Toronto, Ontario, Canada, on the 15th December 2006 (ref: UHN REB 05-0745-B). |
| Health condition(s) or problem(s) studied | Postoperative pain during laparoscopic cholecystectomy |
| Intervention | During laparoscopic cholecystectomy depending on the randomised three groups patients will receive three doses of pregabalin 50 mg/75 mg, first dose one hour after surgery and then every twelve hours or oral placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Pregabalin |
| Primary outcome measure(s) |
1. Postoperative pain score (Numerical Rating Score [NRS]) in Post Anaesthesia Care Unit (PACU), one hour, six hours, day one, day two and day seven after surgery at rest and movement |
| Key secondary outcome measure(s) |
1. General tolerability of the regimens |
| Completion date | 21/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 135 |
| Total final enrolment | 162 |
| Key inclusion criteria | 1. Patients 18 to 65 years of age undergoing cholecystectomy under general anesthesia 2. Able to tolerate standard medications - 1000 mg of acetaminophen and 500 mg of naproxen |
| Key exclusion criteria | 1. Clinically diagnosed acute pancreatitis requiring urgent cholecystectomy 2. Allergy to gabapentin or pregabalin 3. Allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAID) or acetaminophen 4. No analgesic within 24 hours before surgery (other than premedication) 5. Patients with Body Mass Index (BMI) more than 40 6. Serious organ disease 7. Creatinine clearance less than or equal to 60 mL 8. Chronic pain patients requiring more than 30 mg morphine per day or equivalent 9. Severe psychiatric disease 10. Drug addiction 11. Pregnancy 12. Language barrier |
| Date of first enrolment | 21/01/2007 |
| Date of final enrolment | 21/06/2008 |
Locations
Countries of recruitment
- Canada
Study participating centre
M5T 2S8
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/08/2010 | 26/03/2021 | Yes | No |
Editorial Notes
26/03/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
