Knee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery (Cryogenou)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status and phase: Terminated; Phase 4

Conditions: Knee Injuries

Treatments: Drug: standard pain relievers

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05059535

2021-A01321-40

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 3 patient groups, including a placebo group

cryoneurolysis of the saphenous nerve

Experimental group

Description:

A cryoneurolysis of the saphenous nerve will be performed between 7 days and 5 days before the knee arthroplasty

Treatment:

Drug: standard pain relievers

cryoneurolysis of geniculate nerves

Experimental group

Description:

A cryoneurolysis of geniculate nerves will be performed between 7 days and 5 days before the knee arthroplasty

Treatment:

Drug: standard pain relievers

control

Placebo Comparator group

Description:

No cryoneurolysis will be performed before the knee arthroplasty

Treatment:

Drug: standard pain relievers