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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSouth Egypt Cancer Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group I (Low dose)Active comparator 1 intervention
Group B: Group II (High dose)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
24 hours

Secondary outcomes

1

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).

Time frame
2-24 hours postoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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