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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Abdominal Surgeries
• Intervention / Treatment: Drug: Pregabalin retard 82.5 mg; Drug: Pregabalin retard 165 mg

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I (Low dose); Participants of this Arm will take pregabalin retard 82.5 mg orally with a sip of water, 1-2 hours before induction of anesthesia.	Drug: Pregabalin retard 82.5 mg; Oral Administration 1-2 hours before elective laparoscopic abdominal surgery
Active Comparator: Group II (High dose); Participants of this Arm will take pregabalin retard 165 mg orally with a sip of water, 1-2 hours before induct	Drug: Pregabalin retard 165 mg; Oral Administration 1-2 hours before elective laparoscopic abdominal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative opioid consumption (IV morphine equivalents) during the first 24 postoperative hours	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2-24 hours postoperative

Collaborators and Investigators

• Sponsor: South Egypt Cancer Institute

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pregabalin; Pain scores; Laparoscopic abdominal surgery; Total opioid consumption
• Other Study ID Numbers: 18-2026-809

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No