Skip to content

Effect of pregabalin in acute post-operative pain and functional recovery for laparoscopic cholecystectomy

Effect of pregabalin in acute post-operative pain and functional recovery for laparoscopic cholecystectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN01000893
Enrollment
135
Registered
2007-02-13
Start date
2007-01-21
Completion date
Unknown
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain during laparoscopic cholecystectomy Surgery Pain

Interventions

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

Sponsors

Pfizer (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026