Post-operative Analgesic Effect of Oral Nefopam: a Randomized Controlled Trial

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

High tibial osteotomy is a common procedure in orthopedic surgery; it is highly standardized (incision location and size, the volume of periosteal lesion, implanted material). It is associated with short recovery period but intense postoperative pain during first 24 hours. The surgical wound has a comprehensive innervation by saphenous and a terminal muscular branches of tibial nerve. These conditions allow reproducible measurements of analgesic drugs effects in postoperative period.

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.

We 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 high tibial osteotomy. 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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon
• Treatments: Nefopam

Criteria

Inclusion Criteria:

• adult patients scheduled for a high tibial osteotomy 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