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临床试验/NCT01696188
NCT01696188已完成不适用

Comparison of In-Plane vs. Out-of-Plane Ultrasound-Guided Approach for Interscalene Nerve Catheters: a Prospective, Randomized Trial

Thomas Jefferson University2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2012年7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
84
试验地点
2
主要终点
Visual Analog Scale Pain Scores

研究概览

简要总结

This is a randomized, double-blinded, prospective study designed to compare two approaches (in the plane of the ultrasound beam and out of the plane of the ultrasound beam) to placing an interscalene nerve block and catheter for pain control after open shoulder surgery. Both approaches have been used successfully but neither has been proven to be superior. Our endpoints are pain scores, time for block placement, and catheter dislodgements. We hypothesized that patients with the out-of-plane approach would have decreased pain and fewer catheter dislodgements.

详细描述

Interscalene nerve block is an effective method of analgesia for surgery of the upper extremity. Perineural interscalene catheters offer the advantage of extended pain relief up to 48 hours after shoulder surgery. This is a prospective, randomized trial designed to compare two approaches (posterior and anterolateral) to interscalene continuous nerve catheter placement for analgesia after open shoulder surgery (open rotator cuff repair, total shoulder arthroplasty or revision, hemi-arthroplasty, or proximal humerus open reduction internal fixation). Specifically, the objectives of this study are to compare measured pain scores, opioid consumption, and catheter dislodgements. We hypothesize that the anterolateral approach will produce lower pain scores, less opioid consumption, and fewer catheter dislodgements.

All patients undergoing open shoulder surgery will be recruited and enrollment in the study will not deviate from the current standard of care at Thomas Jefferson University Hospital. All nerve blocks will be placed by a regional anesthesiologist or a fellow in regional anesthesia. Patient medical history will be obtained and blocks will be placed per usual protocol. Block efficacy will be assessed by physical exam immediately after placement by the anesthesiologist and another member of the research team. Operative details, including medications given, will be recorded.

Patient pain scores and medications given in the PACU will be recorded. Supplementary analgesics will be available. Pain scores, medications given, and sensory examinations will be recorded for 48 hours postoperatively. Data will be analyzed both at the conclusion of the study and at several interims before that.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

  • speaks English

排除标准

  • children,
  • neuropathy in operative arm

结局指标

主要结局

Visual Analog Scale Pain Scores

时间窗: 24 hours

Pain was rated from 0 (no pain) to 10 (worst pain imaginable)

次要结局

  • Catheter Dislodgements(24 hours)
  • Opioid Consumption(48 hours)
  • Time for Block Placement(immediately post-procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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