Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO)
- Registration Number
- NCT06349798
- Lead Sponsor
- University Hospital, Tours
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 546
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group NaCl 0.9% - Nefopam "bolus" group Nefopam - Nefopam "CIVI" group Nefopam -
- Primary Outcome Measures
Name Time Method Cumulative morphine consumption from the end of surgery (Day 0 - Hour 0) to the first 24 hours after surgery, expressed in mg of intravenous morphine (including titration in the Post-Anesthesia care Unit PACU). between Day 0 - Hour 0 and Hour 24 post surgery
- Secondary Outcome Measures
Name Time Method Length of stay. At Day 0 - Hour 0 up to Day 5 or at discharge Time to abandon canes/crutches. At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6 Chronic pain at 6 months (at rest and walking) using a standardized phone questionnaire. At Month 6 Maximum self-assessed pain using the Numeric Rating Scale ranging from 0 (no pain) to 10 (maximum pain) at rest in the PACU, at rest and on walking between PACU discharge and Hour 24, at Hour 24, and at hospital discharge. at PACU, between PACU discharge and Hour 24, at Hour 24 and at Day 5 of hospital discharge Time to return to walking. At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6 Time to climb stairs. At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6 Financial impact of spreading the recommended strategy following the results of the clinical study, estimated per year and over a 5-year period, from the point of view of the French Health Insurance and from the hospital perspective. 5 years These financial impacts will be estimated using budget impact models.
Time to leave room. At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6 Incidence of patients with morphine side effects at Hour 24 and up to day 5 Incidence of patients with morphine side effects: nausea, vomiting, use of anti-nausea medication, pruritus requiring modification of management, urinary retention, use of urinary antispasmodics or urethral catheterization/suprapubic catheter, or abnormal drowsiness.
Opioid analgesic consumption between days 1 and 5 or at hospital discharge at Hour 24 and up to day 5 Neuropathic pain score (DN2)The DN2 is a simplified version of the DN4, with 7 items: burning, painful cold, electric shocks, tingling, pins and needles, numbness, itching (scored 0=absent, 1=present). At Hour 24 and Month 6 Incidence of all serious AEs during patient follow-up and non-serious AEs. at Hour 24 and up to day 5
Trial Locations
- Locations (2)
Anaesthesia - Intensive care
🇫🇷Poitiers, France
Anesthesia - intensive care
🇫🇷Tours, France