Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO) (NCT06349798) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO)
France546 participantsStarted 2024-04
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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).
Timeframe: between Day 0 - Hour 0 and Hour 24 post surgery