Actively Recruiting
Post-operative Analgesic Effect of Oral Nefopam
Led by Hospices Civils de Lyon · Updated on 2026-05-14
50
Participants Needed
1
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary knee arthroplasty by total prosthesis is a painful surgery, performed on patients with advanced gonarthrosis (stage III), thus already presenting hyperalgesia and hyperalgesia and allodynia. This terrain makes the risk of postoperative hyperalgesia but also of persistent postoperative risk of persistent post-surgical pain. Nefopam is a non-opioid centrally acting analgesic drug used as a part of multimodal analgesia. The opioid-sparing effect of nefopam is still controversial across various surgical procedures. In France nefopam is only available as a parenteral formulation; however it is often administered orally. There is currently no study addressing the efficacy of oral nefopam for the postoperative pain management including pain prevention. The investigators conduct a prospective, double-blinded randomized controlled study with the main objective to examine the effect of perioperative orally administered nefopam on postoperative pain after a total knee arthroplasty. Secondary objectives include the quantification of wound allodynia, analysis of adverse events, clinical outcomes, and a pharmacokinetic study of orally given nefopam (plasma and cerebrospinal fluid dosage).
CONDITIONS
Official Title
Post-operative Analgesic Effect of Oral Nefopam
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients scheduled for total knee arthroplasty under spinal anesthesia at Hopital de la Croix Rousse, Hospice Civils de Lyon, France
- ASA (American Society of Anesthesiology) class between 1 and 3
- Written informed consent provided
You will not qualify if you...
- Known allergy to nefopam or history of seizures, urinary retention, benign prostate hyperplasia, angle glaucoma, ischemic cardiomyopathy awaiting revascularization, or atrial fibrillation
- Medical conditions affecting nefopam metabolism, including chronic kidney failure with GFR <30 mL/min/1.73m2, liver failure, or current treatment with rifampicin, carbamazepine, azole fungicides, or macrolides
- Current use of benzodiazepines, anxiolytics, antidepressants, histamine H1 antagonists, neuroleptics, baclofen, thalidomide, or barbiturates
- History of gastric or esophageal surgery
- Phenylketonuria
- Pregnancy or breastfeeding
- Past use of oral nefopam
AI-Screening
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Trial Site Locations
Total: 1 location
1
Département d'Anesthésie Réanimation, Groupement Hospitalier Nord, Hospices Civils de Lyon
Lyon, Lyon, France, 69004
Actively Recruiting
Research Team
F
Frederic AUBRUN, MD/PHD
CONTACT
S
Solene PANTEL
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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