Efectividad de la Radiofrecuencia Pulsada Del Nervio Safeno en el Manejo Del Dolor en Artroplastia de Rodilla
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 主要终点
- Pain 6 months after sugery
研究概览
简要总结
Approximately 40% of patients undergoing total knee arthroplasty develop acute to moderate post operative pain. Furthermore 20-30% develop chronic post operative pain. The objective of this work is to study the effectiveness and safety of pulsed radiofrequency of the saphenous nerve realized during the pre-operative period of total knee arthroplasty. The study design is a randomized, blinded clinical trial. Patients scheduled for total knee arthroplasty are divided into two groups. The first group procedure consists in pre-operative pulsed radiofrequency under ultrasound guidance of the saphenous nerve and standard postoperative pain management by the pain clinic. The second group receives only the standard postoperative pain management by the pain clinic. Patient follow ups are performed 3 times (after 2 weeks, 2 months and 6 months) within a period of 6 months, evaluating pain severity using the VAS.
详细描述
Methods
Study Design
Randomized, blinded clinical trial. Patients are divided into two groups, one to saphenous nerve block with pulsed radiofrequency guided by ultrasound is applied plus standard pain management by the Pain Clinic, the other one only standard pain management by the Pain Clinic. A 6-month follow-up is evaluating pain by VAS and function by the WOMAC scale
Objectif
Asses the effectivity and safety of preoperatory saphenous nerve pulsed radiofrecuency in total knee arthroplasty between 2014 and 2015 in the Fundación Santa Fe de Bogotá Hospital.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from the Center for Care of Articular Replacements from Fundación Santa Fe University Hospital programed for knee replacement surgery.
- •ASA I-III
- •Informed consent
- •Unilateral Knee Replacement
排除标准
- •Neurologic conditions associated with hyperalgesia or allodynia
- •Cognitive impairment
- •Psychiatric conditions
- •Contraindication for the use of local anesthetics
- •Bleeding disorders
- •Pacemaker or ICD
- •Septic arthritis or any infection in the surgical site
- •Additional surgical procedure during the surgical act
研究组 & 干预措施
No pulsed radiofrequency
Procedure consists of a mock incision at the pulsed radiofrequency needle insertion site and standard perioperative pain management by the pain clinic (femoral catheter and PCA)
干预措施: Mock incision (Procedure)
Pulsed Radiofrequency
Procedure consists in pre-operative pulsed radiofrequency under ultrasound guidance of the saphenous nerve and standard postoperative pain management by the pain clinic (femoral catheter and PCA)
干预措施: Pulsed radiofrequency of the saphenous nerve before knee replacement surgery (Procedure)
结局指标
主要结局
Pain 6 months after sugery
时间窗: 6 months
VAS Pain value 6 months after the knee replacement surgery. The Visual Analog Scale to assess pain ranges from 0mm to 100mm, where 0 is the 'absence of pain' and 100 is 'the worst pain imaginable by the patient'. Lower values in the scale represent a better outcome for the patient.
次要结局
- Pain on postoperative month 2(2 months)
- Opioid consumption during the postoperative period(3 days)
- Pain on postoperative week 2(15 days)
- Pain on postoperative days 0-3(3 days)
研究者
Carlo Guerrero Nope
anesthesiologist specialist in pain management
Fundación Santa Fe de Bogota