Postoperative analgesic effect of orally administrated nefopam after a total knee arthroplasty: a randomized controlled trial (NefPO)
- Conditions
- Postoperative pain after a total knee arthroplastyMedDRA version: 20.0Level: SOCClassification code: 10042613Term: Surgical and medical procedures Class: 25Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Registration Number
- CTIS2024-513796-40-00
- Lead Sponsor
- Hospices Civils De Lyon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 46
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.
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method