Tapentadol vs Pregabalin for Postoperative Pain in Lower Limb Surgery

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).

NCT Number	NCT07587645
Lead Sponsor	ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"
Conditions	Acute Postoperative Pain, Lower Limb Surgery
Enrollment	46 participants
Start Date	2024-06-19
Primary Completion	2024-07-03 (estimated)
Study Completion	2024-07-05 (estimated)
Updated on ClinicalTrials.gov	2026-05-15