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Tapentadol vs Pregabalin for Postoperative Pain in Lower Limb Surgery

NCT07587645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-05-15

No results posted yet for this study

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).

Conditions

  • Acute Postoperative Pain
  • Lower Limb Surgery

Interventions

DRUG

Tapentadol

Tapentadol 50 mg immediate-release oral tablet administered every 12 hours for 72 hours preoperatively (total of 6 doses).

DRUG

Pregabalin

Pregabalin 75 mg oral capsule administered every 24 hours for 72 hours preoperatively (total of 3 doses).

Sponsors & Collaborators

  • ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07587645 on ClinicalTrials.gov