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Post-operative Analgesic Effect of Oral Nefopam

RecruitingPhase 2Ages 18 Years - 75 YearsAllHospices Civils de Lyon
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In plain words

What the trial is, and whether it could suit you

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 p

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📋 Eligibility rules (as published)
Inclusion Criteria: * adult patients scheduled for a total knee arthroplasty under spinal anesthesia at the Hopital de la Croix Rousse, Hospice Civils de Lyon, France. * ASA (American Society of Anesthesiology) class between 1 et 3. * written informed consent Exclusion Criteria: * 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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What it tests

  • Oral nefopam
  • Placebo
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Where

1 site
Département d'Anesthésie Réanimation, Groupement Hospitalier Nord, Hospices Civils de Lyon
Lyon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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