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临床试验/NCT03807505
NCT03807505已完成不适用

Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery

Stanford University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年6月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Pain score

研究概览

简要总结

The goal of this study is the evaluation of erector spinae plane (ESP) blocks as an alternative to interscalene brachial plexus nerve blocks for rotator cuff repair and total shoulder arthroplasty procedures. Currently, single shot interscalene nerve blocks are performed for rotator cuff repair surgeries, and interscalene nerve catheters are placed for total shoulder arthroplasty surgeries. Erector spinae plane blocks are commonly used as part of the anesthetic plan for other surgeries, but less so for shoulder surgeries. The investigators would like to study whether an ESP block can provide similar pain control compared to an interscalene nerve block, with less risk of upper extremity motor block and phrenic nerve block.

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
Single (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
否

入选标准

  • •All adult patients (18 years and over) scheduled for rotator cuff surgery or total shoulder arthroplasty surgery requiring a nerve block as part of their anesthetic care

排除标准

  • •concomitant life-threatening injuries and other concomitant injuries causing significant pain.
  • •pregnancy,
  • •any condition impairing patient's ability to consent to participation in study
  • •an existing condition contraindicating a nerve block, i.e. nerve injury, existing bleeding disorder
  • •infection in the vicinity of the block, and patient refusal.

研究组 & 干预措施

Interscalene nerve block

Active Comparator

Patients undergoing rotator cuff repair surgery or total shoulder arthroplasty will undergo a single shot interscalene brachial plexus nerve block or an interscalene brachial plexus nerve catheter. In the preoperative area, all participants will be asked baseline indicators of pain level via a Numeric Rating Scale (NRS, 0-10, where 0 is no pain and 10 is the worst imaginable pain) and diaphragmatic excursion will be measured bilaterally using ultrasonography before nerve block placement. Motor and sensory exams will also be performed. The same parameters will be measured 30 minutes after the block is performed. In the recovery room, those with nerve catheters will receive a dose of local anesthetic. All patients will have the same parameters measured 30 minutes postoperatively.

干预措施: Interscalene brachial plexus nerve block (Procedure)

Erector Spinae Plane block

Active Comparator

Patients undergoing rotator cuff repair surgery or total shoulder arthroplasty will undergo a single shot erector spinae plane block or receive erector spinae plane catheter. In the preoperative area, all participants will be asked baseline indicators of pain level via a Numeric Rating Scale (NRS, 0-10, where 0 is no pain and 10 is the worst imaginable pain) and diaphragmatic excursion will be measured bilaterally using ultrasonography before nerve block placement. Motor and sensory exams will also be performed. The same parameters will be measured 30 minutes after the block is performed. In the recovery room, those with nerve catheters will receive a dose of local anesthetic. All patients will have the same parameters measured 30 minutes postoperatively.

干预措施: Erector spinae plane block (Procedure)

结局指标

主要结局

Pain score

时间窗: 48 hours

Pain scores for all patients will be recorded through the first 48 hours postoperatively using the Numeric Rating scale (ranging from 0 to 10, 0 is no pain and 10 is the worst imaginable pain).

Incidence of diaphragmatic paresis or paralysis

时间窗: Before block placement, and 30 minutes after catheter is bolused in recovery

Change in diaphragmatic excursion (measured bilaterally using ultrasonography) from before block placement to 30 minutes after catheter is bolused in recovery

次要结局

  • Opioid Consumption(48 hours)
  • Patient satisfaction(72 hours)
  • Brachial plexus motor exam change(Before block placement, and 30 minutes after catheter is bolused in recovery)
  • Incentive spirometry volume change(24 hours)
  • Adverse effects(72 hours)
  • Brachial plexus sensory exam change(Before block placement, and 30 minutes after catheter is bolused in recovery)

研究者

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

Chi-Ho Ban Tsui

Professor of Anesthesiology, Perioperative and Pain Medicine

Stanford University

研究点 (1)

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