跳至主要内容
临床试验/NCT01615939
NCT01615939终止4 期

A Randomized Controlled Trial Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block

Northwestern University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
17
试验地点
1
主要终点
Temporary Neurologic Symptoms Between Groups

研究概览

简要总结

The purpose of this study is to compare the incidence of postoperative symptoms of neurologic injury after a single shot infragluteal-parabiceps sciatic nerve block versus a continuous infragluteal-parabiceps sciatic nerve catheter.

详细描述

There are a limited number of prospective studies in the literature examining the risk of neurologic injury and symptoms after sciatic nerve blocks. The incidence of transient neurological symptoms after a continuous catheter is not well reported.

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

入选标准

  • all patients ( ≥18 and ≤ 80) who are scheduled to undergo elective scheduled foot surgery and agreed to receive a sciatic nerve catheter as a part of their postoperative pain management. this study.

排除标准

  • history of hemostatic abnormalities
  • chronic pain syndrome
  • a foot deformity restricting normal foot movement
  • severe liver or renal disease
  • a preexisting neurologic disorder
  • patient refusal to participate
  • the presence of language barrier that prohibits proper communication with patient.

研究组 & 干预措施

Single Shot Sciatic Nerve Block

Active Comparator

Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).

干预措施: Bupivacaine (Drug)

Continuous Sciatic Nerve Block

Active Comparator

Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Temporary Neurologic Symptoms Between Groups

时间窗: 1 month

Temporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion

次要结局

  • Pain Control(72 hrs)
  • Participant Satisfaction With Anesthesia(24 hours)

研究者

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

Antoun Nader

Professor of Anesthesiology

Northwestern University

研究点 (1)

Loading locations...

相似试验