Cryoneurolysis of the Saphenous Nerve or Geniculate Nerves: Impact on Postoperative Pain and Rehabilitation in Prosthetic Knee Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- 90 ° flexion pain 2 days after the arthroscopy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
cryoneurolysis of the saphenous nerve
A cryoneurolysis of the saphenous nerve will be performed between 7 days and 5 days before the knee arthroplasty
干预措施: standard pain relievers (Drug)
cryoneurolysis of geniculate nerves
A cryoneurolysis of geniculate nerves will be performed between 7 days and 5 days before the knee arthroplasty
干预措施: standard pain relievers (Drug)
control
No cryoneurolysis will be performed before the knee arthroplasty
干预措施: standard pain relievers (Drug)
结局指标
主要结局
90 ° flexion pain 2 days after the arthroscopy
时间窗: 2 days
Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm
次要结局
- 90 ° flexion pain 7 days after the arthroscopy(7 days)
- pain at rest at Day 7(7 days)
- pain at rest at Day 30(30 days)
- pain at rest at Day 90(90 days)
- 90 ° flexion pain 1 day after the arthroscopy(1 day)
- 90 ° flexion pain 90 days after the arthroscopy(90 days)
- 90 ° flexion pain 30 days after the arthroscopy(30 days)
- pain at rest at Day 1(1 day)
- pain at rest at Day 2(2 days)