Postoperative Analgesic Effect of Orally Administrated Nefopam After a Total Knee Arthroplasty: a Randomized Controlled Trial

Who is this study for? Patients with Postoperative Pain After a High Tibial Osteotomy
What treatments are being studied? Oral Nefopam
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Département d'Anesthésie Réanimation, Groupement Hospitalier Nord, Hospices Civils de Lyon
RECRUITING
Lyon
Contact Information
Primary
Frederic AUBRUN, MD/PHD
Frederic.aubrun@chu-lyon.fr
4 72 07 26 11
Backup
Solene PANTEL
solene.pantel02@chu-lyon.fr
4 26 73 27 25
Time Frame
Start Date: 2021-06-29
Estimated Completion Date: 2026-11-15
Participants
Target number of participants: 40
Treatments
Experimental: NEFOPAM 60mg PO/ 8 hours
Oral administration of nefopam 60mg 2 hours before the surgery following by 60mg each 8h for 24h.
Placebo_comparator: Placebo
Oral administration of a placebo 2 hours before the surgery following by one administration each 8h for 24h.
Related Therapeutic Areas
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov

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