Tapentadol vs Pregabalin for Postoperative Pain in Lower Limb Surgery (NCT07587645) | Clinical Trial Compass
CompletedNot Applicable
Tapentadol vs Pregabalin for Postoperative Pain in Lower Limb Surgery
Mexico46 participantsStarted 2024-06-19
Plain-language 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).
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-50 years
* ASA physical status I or II
* Body mass index between 18 and 35 kg/m²
* Scheduled for elective lower limb surgery under neuraxial anaesthesia
* Willing to provide written informed consent
Exclusion Criteria:
* Chronic use of analgesics or gabapentinoids
* Known hypersensitivity to tapentadol or pregabalin
* Pre-existing chronic pain
Elimination Criteria:
* Hypersensitivity reaction to any study drug during administration
* Hemodynamic shock of any etiology
* Requirement for advanced airway management or postoperative mechanical ventilation
* Surgical duration exceeding 120 minutes
* Requirement of an epidural catheter dose within the first two postoperative hours
* Voluntary withdrawal of consent at any point
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared tapentadol and pregabalin for pain after lower limb surgery — since the study is now completed, has the results data been published, and does it show any meaningful difference in pain scores between the two drugs that might influence which one you'd recommend for me?
2Since this trial was listed as Phase NA, which often applies to pragmatic or comparative drug studies rather than early-stage testing, what does that mean for how confident we can be in the safety and effectiveness findings compared to a Phase 3 trial?
3Both tapentadol and pregabalin are already approved medications, but they work very differently — tapentadol is an opioid-based painkiller and pregabalin affects nerve signals — so based on my specific surgery and health history, which approach would you lean toward for managing my postoperative pain?
4The trial measured pain using a Numeric Rating Scale after lower limb surgery — do you know what level of pain reduction the trial actually found, and would that level of relief be considered clinically meaningful for someone in my situation?
5Are there standard post-surgical pain management options you'd consider before or instead of either of these medications, and how would you weigh those against what this completed trial might suggest?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain intensity by Numeric Rating Scale (NRS)
Timeframe: At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival