drugset / Trial / NCT06349798

Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO)

NCT06349798

Phase 3 Not yet recruiting 546 enrolled University Hospital, Tours
RandomizedParallel-groupTriple-blindTreatment

Summary

NEFARTHRO is a multicentric randomized controlled trial comparing the effects of discontinuous infusions of nefopam (bolus) versus continuous infusion of intravenous nefopam (via an infusion pump) versus placebo on the opioid-request during the first 24 hours following a Total Hip arthroplasty, as part of multimodal analgesia including at least paracetamol and a Non-Steroidal Anti-Inflammatory Drug (NSAID). The primary endpoint is cumulative morphine consumption for the first postoperative 24 hours, expressed in mg of iv equivalent morphine, including titration in the Post Anesthesia Care Unit (PACU). Patients will be followed during 6 months.

Timeline

Start
2024-04
Primary completion
2026-09
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Nefopam Small molecule 20 mg Intravenous
Subject Nefopam Small molecule 100 mg Intravenous

Indications

No indication recorded.