About this trial
The goal of this clinical trial is to detect whether pregabalin retard (82.5 mg or 165 mg) improves analgesia after elective laparoscopic abdominal surgery in adults. It will also evaluate the safety of both doses.
The main questions it aims to answer are:
Does the higher dose (165 mg) reduce the total amount of opioids needed in the first 24 hours after surgery compared to the lower dose (82.5 mg)? Do the pain scores differ between the two doses? Are there differences in side effects between the two doses?
Researchers will compare two different doses of pregabalin retard to determine which provides better pain control with fewer side effects.
Participants will:
Take one dose of pregabalin retard (82.5 mg or 165 mg) before surgery Receive standard anesthesia and multimodal pain treatment Have their pain levels and opioid use monitored for 24 hours after surgery Be assessed for side effects such as dizziness, nausea, or sedation
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years
ASA physical status I-III
Scheduled for elective laparoscopic abdominal surgery under general anesthesia (e.g. laparoscopic cholecystectomy, appendectomy, diagnostic/therapeutic laparoscopic procedures without expected conversion to open surgery)
Ability to understand the NRS pain scale and the study procedures
Disqualifiers
Known allergy or intolerance to pregabalin, gabapentinoids, or study medications
Chronic opioid use (daily use >30 mg oral morphine equivalent for >2 weeks preoperatively)
Regular use of gabapentin or pregabalin within 30 days
Severe renal impairment (eGFR < 30 mL/min/1.73 m²) or on dialysis
Trial design
Parallel
Treatments tested in this trial
Pregabalin retard 82.5 mg
DrugOral Administration 1-2 hours before elective laparoscopic abdominal surgery
Pregabalin retard 165 mg
DrugOral Administration 1-2 hours before elective laparoscopic abdominal surgery
Treatment groups
Trial outcomes
Primary outcomes
Cumulative opioid consumption (IV morphine equivalents) during the first 24 postoperative hours
Secondary outcomes
Postoperative pain intensity
Visual Analog Scale (0-10) at rest and during movement at predefined time points (2,4, 6,8 12,18 and 24h).
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: