Post-operative Analgesic Effect of Oral Nefopam (NefPO)

Civil Hospices of Lyon

Status and phase: Enrolling; Phase 2

Conditions: Postoperative Pain After a Total Knee Arthroplasty

Treatments: Drug: Placebo; Drug: Oral nefopam

Study type: Interventional

Funder types: Other

Identifiers

NCT04576078

69HCL20_0111

2020-002955-40 (EudraCT Number)

Details and patient eligibility

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

NEFOPAM 60mg PO/ 8 hours

Experimental group

Description:

Oral administration of nefopam 60mg 2 hours before the surgery following by 60mg each 8h for 24h.

Treatment:

Drug: Oral nefopam

Placebo

Placebo Comparator group

Description:

Oral administration of a placebo 2 hours before the surgery following by one administration each 8h for 24h.

Treatment:

Drug: Placebo