Not Yet RecruitingNot Applicable

Effect of Low-dose Pregabalin Retard (82.5 mg) Versus Standard-dose Pregabalin Retard (165 mg) on Postoperative Pain and Opioid Consumption After Elective Laparoscopic Abdominal Surgery

80 participantsStarted 2026-04

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * Written informed consent obtained Exclusion Criteria: * 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 * Severe hepatic impairment (Child-Pugh C) * Uncontrolled epilepsy or other major neurological disorder * Severe psychiatric disease, alcohol or substance abuse * Pregnancy or breastfeeding * Planned postoperative ICU admission for reasons other than routine overnight monitoring * Conversion to open abdominal surgery (these patients will be analyzed in sensitivity or excluded, predefined in analysis plan)

What they're measuring

Cumulative opioid consumption (IV morphine equivalents) during the first 24 postoperative hours

Timeframe: 24 hours

Trial details

NCT IDNCT07456761

SponsorSouth Egypt Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11