Postoperative analgesic effect of orally administrated nefopam after a total knee arthroplasty: a randomized controlled trial (NefPO)
Date de révision : 27/04/2026
50 participants
Homme Femme
A partir de 18 ans
Date de début de recrutement : 28/01/2025
Critères :
Critères d'inclusion :
- Patient over 18.
- Patient scheduled for primary PTG under spinal anesthesia, in the orthopedics department of the Croix-Rousse hospital.
- Patient with an American Society of Anesthesiology (ASA) score between I and III.
- Patient having agreed to take part in the study and having signed the informed consent form.
- Patient entitled to social security benefits.
- Patient willing to return for all study visits.
Critères d'exclusion :
- Any contraindication for nefopam (known hypersensitivity, past medical history of seizures, urinary retention, benign prostate hyperplasia, angle glaucoma, ischemic cardiomyopathy waiting for revascularization, atrial fibrillation)
- Medical conditions known to influence the pharmacokinetics of nefopam (chronic kidney failure with Glomerular Filtration Rate (GFR) <30mL/min/1,73m2, liver failure, current treatment with rifampicin, carbamazepine, azoles fungicides, macrolides)
- Current treatment with benzodiazepines, anxiolytics, antidepressants, histamine H1 antagonists, neuroleptics, baclofen, thalidomide, barbiturates
- Medical history of gastric or esophageal surgery.
- Phenylketonuria
- Pregnancy or breastfeeding
- Past use of oral nefopam
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