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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07456761

Enrollment

Registered

2026-03-06

Start date

2026-04-01

Completion date

2026-12-01

Last updated

2026-04-02

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

Conditions

Laparoscopic Abdominal Surgeries

Keywords

Pregabalin, Pain scores, Total opioid consumption, Laparoscopic abdominal surgery

Brief 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

Interventions

DRUGPregabalin retard 82.5 mg

Oral Administration 1-2 hours before elective laparoscopic abdominal surgery

DRUGPregabalin retard 165 mg

Oral Administration 1-2 hours before elective laparoscopic abdominal surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Postoperative pain intensity	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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026