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临床试验/NCT02415465
NCT02415465已完成不适用

Continuous Adductor Canal Block (CACB) vs. Combined Spinal Epidural (CSE) in Total Knee Arthroplasty

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
157
试验地点
2
主要终点
Ambulation Distance in feet

研究概览

简要总结

Purpose: Compare continuous adductor canal block (CACB) to Combined Spinal Epidural (CSE) for total knee arthroplasty in terms of mobility, post-operative pain, and analgesic use.

Hypothesis: CACB will provide better mobility than CSE post operatively.

详细描述

Purpose: Compare continuous adductor canal block (CACB) to Combined Spinal Epidural (CSE) for total knee arthroplasty in terms of mobility, post-operative pain, and analgesic use.

Hypothesis: CACB will provide better mobility than CSE post operatively.

Background/Scientific Review:

Total knee arthroplasty (TKA) is associated with varying degrees of pain post operatively ranging from mild to severe despite the use of comprehensive multimodal analgesic regimens1. Optimizing pain relief is vital for functional recovery after total knee arthroplasty2. Peripheral nerve blocks have been commonly used to improve pain relief and reduce opioid requirements. The addition of nerve blocks involving the femoral nerve have been shown to provide superior pain control3 and shortened hospital stay compared to epidural or intravenous patient controlled analgesia alone1. However, femoral nerve blocks can result in quadriceps weakness leading to functional impairment and an increased risk of falling post operatively4. Unlike Femoral Nerve Blocks (FNB), adductor canal blocks (ACB) are predominantly sensory blocks which preserve quadriceps muscle strength and ambulation ability better than FNBs, while providing equivalent pain relief5-9.

Recent randomized studies have also shown ACB to be superior to placebo in the setting of spinal and general intraoperative anesthesia in terms of ambulation, pain control, and opioid consumption10-12. In a recent retrospective cohort study, the addition of ACB to local infiltration analgesia (LIA) was associated with further improvement in early ambulation benchmarks and a higher rate of home discharge compared with only LIA9. While CACB and CSE are used as part of routine care at Rush University Medical Center and around the country, there have been no studies directly comparing CACB to CSE.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Any patient scheduled for a primary unilateral TKA.

排除标准

  • Partial knee replacement,
  • chronic opioid use,
  • history of alcohol or drug abuse,
  • preexisting neuropathy in operative limb,
  • allergy to local anesthetics,
  • ASA Class >3,
  • patients who decline to participate,
  • BMI >40,
  • sleep apnea.

结局指标

主要结局

Ambulation Distance in feet

时间窗: daily after surgery until discharge from hospital, expected average up to 5 days

Patient ambulation distance will be measured daily after surgery until discharge from hospital

次要结局

  • Straight Leg Raise(daily after surgery until discharge from hospital, expected average up to 5 days)
  • Pain as measured by numeric pain score(daily after surgery until discharge from hospital, expected average up to 5 days)
  • Post-operative inpatient opioid consumption (morphine equivalents)(daily after surgery until discharge from hospital, expected average up to 5 days)
  • Quadriceps strength(daily after surgery until discharge from hospital, expected average up to 5 days)
  • Surgery Complications and Adverse Events during inpatient stay(daily after surgery until discahrge from hospital, expected average up to 5 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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