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Postoperative analgesic effect of orally administrated nefopam after a total knee arthroplasty: a randomized controlled trial (NefPO)
EU CTIS ID: 2024-513796-40-00
What this study is testing
The primary objective of this study is to measure whether orally administered nefopam significantly reduces morphine consumption at 24h after total knee replacement (TKR) surgery in adults compared with placebo.
- Phase I and Phase II (Integrated)- Bioequivalence Study
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.