drugset / Trial / NCT07587645
Tapentadol vs Pregabalin for Postoperative Pain in Lower Limb Surgery
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pregabalin | Small molecule | 75 mg | Oral |
| Subject | Tapentadol | Small molecule | 50 mg | Oral |
Indications
No indication recorded.