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ClinicalTrials.gov ID

NCT06349798

Lead Sponsor

University Hospital, ToursOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

546Estimated

Last Update Posted

Apr 5, 2024Actual

Start Date

Apr 2024Estimated

Primary Completion Date

Sep 2026Estimated

Completion Date

Apr 2027Estimated

Official Title

Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO): a Multicentric Randomized Controlled Trial.

Brief 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.

• Total Hip Arthroplasty

• Nefopam
• NaCl 0.9%

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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).
• Participant affiliated to a social security scheme
• Participant's free, informed and written consent

Exclusion Criteria:

• Septic or carcinological surgery
• Allergy to paracetamol, nefopam or NSAIDs
• Angle-closure glaucoma
• Prostate adenoma
• history of convulsion
• Nocturnal pollakiuria in men with more than two risings per night
• Severe hepatic (Child C) or cardiac insufficiency (LVEF < 30%)
• Renal insufficiency with creatinine clearance < 50 mL/ min according to Cockroft's formula
• Active peptic ulcer or history of digestive bleeding or peptic perforation
• Patients with opioid treatment for chronic pain other than coxarthrosis (fentanyl, oral morphine > 50mg/d or equivalent)
• Protected patient: safeguard of justice, guardianship or curatorship
• Incomprehension or inability to use a numerical rating scale or to self-assess/manage pain
• Pregnancy or breast-feeding

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

University Hospital, ToursOTHER

darmonr@ch-blois.fr02 54 55 66 33 ext. +33

echaddouk@ch-chartres.fr02 37 30 30 30 ext. +33

Raphael.CINOTTI@chu-nantes.fr02 53 48 22 30 ext. +33

lea.pascot@chr-orleans.fr02 38 22 97 17 ext. +33

denis.frasca@univ-poitiers.fr05 49 44 38 95 ext. +33

F.REMERAND@chu-tours.fr02 47 47 84 80 ext. +33