Effect of pregabalin in acute post-operative pain and functional recovery for laparoscopic cholecystectomy
| ISRCTN | ISRCTN01000893 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01000893 |
| Secondary identifying numbers | N/A |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Philip Peng
Scientific
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
| Study design | Double blind, randomised, controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Pregabalin |
| Primary outcome measure | 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 2. Time to first analgesic consumption 3. Discharge time from PACU 4. Consumption of analgesics in the postoperative period up to day seven |
| Secondary outcome measures | 1. General tolerability of the regimens 2. Sleep quality 3. Quality of Recovery 40-item questionnaire (QoR-40) 4. Adverse effects including Opioid-Related Symptom Distress Scale (ORSDS) 5. Patient satisfaction |
| Overall study start date | 21/01/2007 |
| Completion date | 21/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
McL 2-405
Toronto
M5T 2S8
Canada
M5T 2S8
Canada
Sponsor information
Pfizer (Canada)
Industry
Industry
17300 Trans-Canada Highway
Kirkland
Quebec
H9J 2M5
Canada
| Website | http://www.pfizer.ca |
|---|---|
"ROR" |
https://ror.org/059g90c15 |
Funders
Funder type
University/education
Support from Department of Anesthesiology and Pain Management, University of Toronto (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
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.
