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Tapentadol vs Pregabalin for Postoperative Pain in Lower Limb Surgery
Sponsor: ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"
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).
Official title: Oral Premedication With Tapentadol Versus Pregabalin for Acute Postoperative Pain in Lower Limb Surgery Under Neuraxial Anesthesia: A Pilot Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2024-06-19
Completion Date
2024-07-05
Last Updated
2026-05-15
Healthy Volunteers
No
Interventions
Tapentadol
Tapentadol 50 mg immediate-release oral tablet administered every 12 hours for 72 hours preoperatively (total of 6 doses).
Pregabalin
Pregabalin 75 mg oral capsule administered every 24 hours for 72 hours preoperatively (total of 3 doses).
Locations (1)
Hospital Regional "General Ignacio Zaragoza," ISSSTE
Mexico City, Mexico City, Mexico