Effect of Oral Nefopam on Postoperative Pain After Knee Surgery
Postoperative Analgesic Effect of Orally Administrated Nefopam After a Total Knee Arthroplasty: a Randomized Controlled Trial
This study is testing if taking oral nefopam can help people feel less pain after knee surgery compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT04576078 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of oral nefopam, a non-opioid analgesic, in managing postoperative pain following total knee arthroplasty. The study is designed as a prospective, double-blinded, randomized controlled trial, focusing on patients undergoing knee surgery under spinal anesthesia. It aims to determine whether perioperative administration of nefopam can reduce pain and prevent the development of persistent postoperative pain. The trial will compare the effects of nefopam against a placebo in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adult patients scheduled for total knee arthroplasty under spinal anesthesia with an ASA class of 1 to 3.
Not a fit: Patients with contraindications to nefopam or those with certain medical conditions affecting its pharmacokinetics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-opioid alternative for managing postoperative pain, potentially reducing reliance on opioids.
How similar studies have performed: While the opioid-sparing effects of nefopam have been debated, this specific approach to oral administration for postoperative pain management is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lyon
- Département d'Anesthésie Réanimation, Groupement Hospitalier Nord, Hospices Civils de Lyon — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Frederic AUBRUN, MD/PHD — Département d'Anesthésie Réanimation, Hopital de la Croix Rousse
- Study coordinator: Frederic AUBRUN, MD/PHD
- Email: Frederic.aubrun@chu-lyon.fr
- Phone: 4 72 07 26 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.