Functional Outcome and Postoperative Analgesia in Total Knee Arthroplasty: a Comparison Between Continuous Adductor Canal Block and Pulsed and Thermal Radiofrequency of Saphenous and Genicular Nerves of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Postoperative morphine consumption
研究概览
简要总结
This randomized, double blind controlled trial is designed to investigate the potential benefits of radiofrequency in terms of analgesia and functional outcome, compared to the conventional continuous adductor canal block, for patients undergoing total knee arthroplasty for osteoarthritis.
详细描述
The aim of this study is to compare the efficacy of two analgesia techniques in patients undergoing Total Knee Arthroplasty (TKA) on the functional recovery and pain control: Pulsed and Continuous Radiofrequency (PRF and TRF) applied respectively to the saphenous nerve and to the genicular nerves of the knee (femoral and sciatic branches) compared with Continuous adductor canal block with local anesthetics (CACB).
The Null Hypothesis is that no difference exists in the functional recovery, in pain medication consumption and in postoperative exercise and physical performance between two groups of patients submitted to TKA with the two different modalities of analgesia.
To test the null hypothesis we hypothesize as clinically relevant:
- a reduction of 30% in the time needed to perform the Timed Up and Go test at 2 days after surgery
- a reduction of 30% in pain medication consumption in the first 24 ore after surgery.
To test the null Hypothesis, 40 patients are needed (20 for each group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of knee Osteoarthritis requiring Total Knee Arthroplasty (TKA)
排除标准
- •Previous TKA (revision surgery)
- •ASA (American Society of Anesthesiology) Classification > 3
- •Known Rheumatologic disease
- •Morbid Obesity (BMI > 45)
- •Inability to perform simple physical tasks (6 minutes walk test, Timed-Up and Go test)
- •Organ transplant, Allergy to opioids, to local anesthetics or other medications used in the study,
- •Chronic use of opioids or sedatives, Contraindication to receive regional anesthesia (e.g. coagulation defect), contraindication to Patient Controlled Analgesia pump (PCA) or inability to use PCA or to comprehend pain scales
研究组 & 干预措施
Pulsed and Continuous Radiofrequency
In this group of patients undergoing total knee arthroplasty (allocation of patients is randomized), Pulsed radiofrequency (PRF) is applied to the saphenous nerve of the knee, associated to Continuous Radiofrequency (TRF) applied to the genicular nerves of the knee . A sham catheter is inserted in the mid-tigh to simulate a continuous adductor canal block, and connected to an infusion of normal saline (assessor and patient blinded to the treatment)
干预措施: Pulsed and Continuous Radiofrequency (Procedure)
Continuous adductor canal block
Continuous Adductor Canal Block
Continuous adductor canal block is performed in this group of patients, with a catheter infusing ropivacaine 0.2% in the first 48 hours after surgery.
The solutions bags are labelled in order to make assessor and patients, blinded to the treatment (Ropivacaine vs Normal Saline)
干预措施: Continuous Adductor Canal Block (Drug)
结局指标
主要结局
Postoperative morphine consumption
时间窗: first postoperative day (first 24 hours)
次要结局
- Visual Analogue Scale (VAS) for pain at rest(first 24 hours after surgery)
- Visual Analogue Scale (VAS) for pain at movement(First 24 hours after surgery)
- Timed-Up and Go Test(2nd postoperative day)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(6 weeks after surgery)
- CHAMPS (Community Healthy Activities Model Program for Seniors) questionnaire(6 weeks after surgery)
- Six minutes walk test(6 weeks after surgery)
- Pain medication consumption(6 weeks after surgery)
研究者
JF Asenjo
Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre