Effect of pregabalin in acute post-operative pain and functional recovery for laparoscopic cholecystectomy
- Conditions
- Postoperative pain during laparoscopic cholecystectomySurgeryPain
- Registration Number
- ISRCTN01000893
- Lead Sponsor
- Pfizer (Canada)
- Brief Summary
2010 results in https://doi.org/10.1093/bja/aeq116 (added 26/03/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 162
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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<br> 2. Time to first analgesic consumption<br> 3. Discharge time from PACU<br> 4. Consumption of analgesics in the postoperative period up to day seven<br>
- Secondary Outcome Measures
Name Time Method <br> 1. General tolerability of the regimens<br> 2. Sleep quality<br> 3. Quality of Recovery 40-item questionnaire (QoR-40)<br> 4. Adverse effects including Opioid-Related Symptom Distress Scale (ORSDS)<br> 5. Patient satisfaction<br>