跳至主要内容
临床试验/NCT02746874
NCT02746874已完成不适用

Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes? A Prospective Randomized Sham-Control Trial With 6 Month Follow Up

Northwestern University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Opioid Consumption After Surgery

研究概览

简要总结

More than 300,000 total knee joint replacement surgeries are performed per year in the United States and safe, effective management of post-operative pain in these patients, often elderly, deconditioned, obese, or with co-morbid diseases like sleep apnea, can be challenging and often require a multidisciplinary, multimodal approach. Opiates have been a mainstay of treatment in the post-operative period with varying degrees of success and complications. Inadequately controlled postoperative pain is not uncommon. Poorly controlled pain inhibits early mobilization and hinders post-operative physical therapy.

A new paradigm for treating post-operative pain following total knee replacement may be the use of cooled radiofrequency ablation (C-RFA) of the articular sensory nerve supply of the knee capsule prior to surgery, to desensitize the knee by blocking sensory afferents to the anterior capsule and thereby decrease post-operative pain. There are several publications that have demonstrated the use of RFA in patients with chronic knee pain from osteoarthritis however the use of RFA in the preoperative management of pain in patients undergoing total knee joint replacement has not been investigated.

The aim of this study is to determine if patients undergoing unilateral total knee replacement obtain any post-operative pain relieving benefits from C-RFA of the articular sensory nerve supply when performed prior to surgery, as compared to sham controls who receive only local anesthetic injections of these same nerves without the benefit of ablation treatment.

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
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • osteoarthritis of the knee scheduled to undergo their first unilateral knee joint replacement
  • willingness to undergo fluoroscopy-guided C-RFA or sham treatment

排除标准

  • pregnancy,
  • severe cardiac/pulmonary compromise,
  • acute illness/infection,
  • coagulopathy
  • bleeding disorder,
  • allergic reactions,
  • contraindications to a local anesthetic

结局指标

主要结局

Opioid Consumption After Surgery

时间窗: 48 hours

Pain medication will be calculated into oral morphine equivalents (ME) for the first 48 hours after surgery. Morphine equivalents determine a patient's cumulative intake of any drugs in the opioid class.

次要结局

  • Oral Morphine Equivalent Milligrams at Baseline.(Pre operative)
  • Oral Morphine Equivalents at Baseline Compared to 48 Hours Post-operative.(48 hours)
  • Medication Quantification Scale III (MQSIII) Score 48 Hours Post-operative.(48 hours)
  • Number of Stairs Climbed on Post-operative Day 2.(Post operative day 2)
  • Distance Walked on Post-operative Day 2.(Post operative day 2)
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score 6 Months Post Operative(6 months post operative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Walega

Associate Professor of Anesthesiology

Northwestern University

研究点 (2)

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