跳至主要内容
临床试验/NCT04426058
NCT04426058Unknown不适用

Complete Motor Sparing Protocol Versus Fascia Iliaca Suprainguinal Technique for Total Hip Arthroplasty, a Prospective Randomized Clinical Trial.

Loyola University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年6月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Measurement of opioid use

研究概览

简要总结

Complete motorsparing protocol (CMP) has been developed to try to minimize the motor nerve block that is created when using Facia iliaca nerve block. The blocks performed in the (CMP) are the cluneal nerve block, Pericapsular nerve group block and lateral femoral cutaneous block. On the clinical trial, the investigators will randomize the participants that meet criteria to CMP or Fascia iliaca Block and compare the amount of opioid needed post op during 24 hours and their pain scores.

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
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

  • Patients ≥ 18 years old
  • Patients undergoing total hip arthroplasty posterior approach.
  • Patients willing to participate and sign informed consent

排除标准

  • Severe COPD/other contraindication to general anesthesia that spinal would be more suitable.
  • Patient with a weight of less than 41 kg
  • Dementia, not alert or Oriented to person, place, or time
  • Chronic pain patient with daily opioid use at home.
  • Patient with allergy to local anesthetics
  • Patient refusal
  • Total hip arthroplasty revision
  • Concomitant pain in different area from operative site.
  • Pregnancy
  • Patient with active infection on the injection sites for the blocks
  • Patients unable or willing to understand or comply with the study protocol

研究组 & 干预措施

CMP

Experimental

Cluneal nerve Block 0.25% bupivacaine 20ml Pericapsular Nerve group block 0.25% Bupivacaine 20ml Lateral femoral cutaneous Block 0.25% bupivacaine 10ml

干预措施: CMP (Drug)

Fascia iliaca

Active Comparator

Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml

干预措施: Fascia Illica (Drug)

结局指标

主要结局

Measurement of opioid use

时间窗: 24 hours

Measurement of opioid use (mg) for pain control after surgery once patient in recovery area

次要结局

  • Measurement of the pain control(24 hours)

研究者

发起方
Loyola University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Scott Byram MD

MD, Associate Professor

Loyola University

研究点 (1)

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