Post-operative Analgesic Effect of Oral Nefopam

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).

NCT Number	NCT04576078
Lead Sponsor	Hospices Civils de Lyon
Conditions	Postoperative Pain After a Total Knee Arthroplasty
Enrollment	50 participants
Start Date	2021-06-29
Primary Completion	2026-12-30 (estimated)
Study Completion	2027-05-15 (estimated)
Updated on ClinicalTrials.gov	2026-05-14