drugset / Trial / NCT07587645

Tapentadol vs Pregabalin for Postoperative Pain in Lower Limb Surgery

NCT07587645

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This pilot randomised controlled trial compared 72-hour oral premedication with tapentadol (50 mg every 12 hours) versus pregabalin (75 mg every 24 hours) for preventing acute postoperative pain in 46 patients undergoing elective lower limb surgery under neuraxial anaesthesia. The primary outcome was pain intensity measured by the Numeric Rating Scale (NRS 0-10) at PACU arrival and at 30, 60, 90, and 120 minutes thereafter. Secondary outcomes included Verbal Rating Scale scores, rescue morphine consumption, and safety (nausea/vomiting, hypersensitivity).

Timeline

Start
2024-06-19
Primary completion
2024-07-03
Completion
2024-07-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pregabalin Small molecule 75 mg Oral
Subject Tapentadol Small molecule 50 mg Oral

Indications

No indication recorded.