Knee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Interventional, comparative, randomized, controlled study versus standard treatment, in 3 parallel groups, monocentric, aiming to demonstrate the superiority of preoperative cryoneurolysis versus no procedure, in patients operated on for knee arthroplasty and receiving standard analgesia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Treatments: Acetaminophen; Analgesics

Criteria

Inclusion Criteria:

• Age ≥ 18 years and ≤ 80 years;

• Patient to undergo prosthetic knee surgery;

• Patient in good health (ASA score 1 to 3);

• Patient able to understand the information related to the study, read the information leaflet and agree to sign the consent form.

Exclusion Criteria:

• Known intolerance to any of the products administered during surgery or cryoneurolysis;

• Patient with an electric implant;

• Patient with a contraindication to cryoanalgesia (coagulation disorders, infections, nerve damage);

• Drug addict patient;

• Intervention on septic bone;

• Chronic renal failure (creatinine clearance <30 mL / min);

• History of cryoglobulinemia, cold urticaria or Raynaud's syndrome;

• Pregnant or breastfeeding woman;

• Patient under guardianship or curatorship, or under a regime of deprivation of liberty;

• Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;

• Patient not beneficiary of a social security scheme.