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临床试验/NCT02121392
NCT02121392已完成不适用

Continuous Adductor Canal Block With Epidural Analgesia for Total Knee Arthroplasty: A Prospective, Randomized, Double-blinded, Placebo-Controlled Trial

University of Chicago1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
165
试验地点
1
主要终点
Morphine Equivalents

研究概览

简要总结

The purpose of this study is to further investigate the efficacy of adductor canal nerve blocks for pain management after total knee replacement. Specifically we are studying adductor canal nerve blocks in conjunction with epidural anesthesia, which is a combination that has not been extensively researched before. Our question is whether combining these modalities will enhance patient satisfaction after surgery and accelerate patients' readiness to discharge.

详细描述

Knee replacement surgery has become increasingly more common in the United States with hundreds of thousands of surgeries performed yearly across the country. Despite that, there is no consensus "standard of care" for optimum pain control regimen after surgery. Pain management after TKA ranges from local tissue injections and patient controlled anesthesia to regional nerve blocks to neuraxial anesthesia. Although regional anesthesia has become more common and widespread, there are wide variations depending on practice setting (academic versus private), equipment available (adductor nerve blocks require ultrasound guidance), level of training of the anesthesiologists and patient selection, among other factors. Another part of the reason for the wide variations in practice is the lack of literature demonstrating clear effectiveness or superiority of one technique over another.

To date adductor canal nerve blocks have been mainly studied in comparison with femoral nerve blocks in terms of their efficacy in controlling pain and their ability to preserve motor function. Adductor canal nerve blocks have been shown in the literature to be an effective method for postoperative pain control in total knee replacement surgery. One of the unique benefits of this particular technique is that the adductor canal nerve block is primarily a sensory block, thereby controlling pain without impairing motor strength. This is useful for total knee replacement surgery as pain is controlled while quadriceps muscle strength is preserved. With well functioning muscles patients are able to fully participate in physical therapy with less strength impairment and reduced risk of falling.

It is our aim to investigate one multimodal approach that combines the strengths of two proven pain management techniques and thereby improve overall postoperative pain control and patient satisfaction. Our hope is to establish a protocol that is safe and effective for patient care.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • end stage degenerative joint disease
  • enrolled for unilateral total knee arthroplasty at the University of Chicago
  • age < 85
  • ability to understand and willingness to sign a written informed consent

排除标准

  • age > 85
  • American Society of Anesthesiologists physical status > 3
  • known hypersensitivity to lidocaine, bupivacaine, ropivacaine or other local anesthetic agents
  • Coagulopathy, specifically INR > 1.5, Platelets < 100, therapy with clopidogrel within 5 days prior to surgery, enoxaparin or fondaparinux within the last 24 hours prior to surgery, patients with anti-phospholipid syndrome requiring aggressive anticoagulation perioperatively
  • History of alcohol or substance abuse (including strong opioids - morphine, oxycodone, methadone, fentanyl, ketobemidone), taking > 50 mg morphine equivalent daily of opioids
  • Pre-existing femoral neuropathy or radiculopathy
  • Patients with poor ability to communicate

研究组 & 干预措施

Epidural Catheter without Adductor Canal Nerve Block Catheter

Sham Comparator

Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.

干预措施: Adductor Canal Nerve Block Sham Catheter (Device)

Epidural Catheter without Adductor Canal Nerve Block Catheter

Sham Comparator

Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.

干预措施: Bupivacaine (Drug)

Epidural Catheter with Adductor Canal Nerve Block Catheter

Experimental

Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.

干预措施: Adductor Canal Nerve Block Catheter (Device)

Epidural Catheter with Adductor Canal Nerve Block Catheter

Experimental

Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Morphine Equivalents

时间窗: 12 hours postoperatively and 20 hours after placement of catheter

次要结局

  • Visual Analog Score for Pain(12 hours postoperatively and 20 hours after placement of catheter)
  • Physical Therapy Ambulation Distance(Daily on postoperative days one and two)
  • Number of Hospital Days Until Discharge Criteria Are Met(within first 3 days (plus or minus 3 days) after surgery)
  • Number of Participants With Adverse Events Related to Adductor Canal Nerve Block Catheter(within first 3 days (plus or minus 3 days) after surgery)
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(3 and 6 weeks)
  • Range of Motion(postoperative day 1 and 2)
  • Range of Motion at 3 and 6 Week Follow up(3 and 6 weeks)
  • Number of Participants With Bleeding Complications at Adductor Canal Nerve Block Catheter Site(within first 3 days (plus or minus 3 days) after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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