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%