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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity Hospital, Tours

About this trial

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.

Eligibility criteria

Qualifiers

Patient aged ≥ 18 years, fluent in French.

Planned primary or secondary total hip replacement, regardless of surgical approach or type of prosthesis.

Receiving paracetamol and ketoprofen postoperatively.

Under general anesthesia or spinal anesthesia (without intrathecal morphine).

Disqualifiers

Septic or carcinological surgery

Allergy to paracetamol, nefopam or NSAIDs

Angle-closure glaucoma

Prostate adenoma

Trial design

Treatments tested in this trial

  • Nefopam
  • Nefopam
  • NaCl 0.9%

Treatment groups

546 Participants
are divided into 3 treatment groups

Sponsors and collaborators