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

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

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Key information

Conditions

Laparoscopic Abdominal Surgeries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pregabalin retard 82.5 mg

Drug

Oral Administration 1-2 hours before elective laparoscopic abdominal surgery

Pregabalin retard 165 mg

Drug

Oral Administration 1-2 hours before elective laparoscopic abdominal surgery

Primary outcomes

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

Time frame: 24 hours

Secondary outcomes

Postoperative pain intensity

Time frame: 2-24 hours postoperative

Visual Analog Scale (0-10) at rest and during movement at predefined time points (2,4, 6,8 12,18 and 24h).

Sponsors and collaborators

Lead sponsor

South Egypt Cancer Institute

Other

Registry information

Official study title

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: a Randomized, Double-blind, Controlled Trial

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Mar 6, 2026
Registry last updated: Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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