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临床试验/NCT04209504
NCT04209504
招募中
不适用

Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block

Duke University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月12日最近更新:

概览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1

概览

简要总结

This prospective observational study aims to evaluate the incidence of hemidiaphragmatic paralysis in patients receiving interscalene brachial plexus nerve block with prolonged neural blockade. English speaking American Society of Anesthesiologists (ASA) 1-3 patients ages 18-80 receiving prolonged interscalene nerve block will be randomized into 3 groups: first group receiving a perineural catheter infusing 0.2% ropivacaine; the second group receiving a single shot injection of 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine and the third receiving 20mL liposomal bupivacaine plus 5mL bupivacaine (to be determined by the attending anesthesiologist).Primary outcome will be incidence of hemidiaphragmatic paralysis postoperative day 1 as measured by point of care (POCUS) ultrasound.

详细描述

This prospective observational study aims to evaluate the incidence of hemidiaphragmatic paralysis in patients receiving interscalene brachial plexus nerve block with prolonged neural blockade. English speaking ASA 1-3 patients ages 18-80 receiving prolonged interscalene nerve block will be randomized into 3 groups first group receiving a perineural catheter infusing 0.2% ropivacaine; the second group receiving a single shot injection of 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine and the third group receiving 20mL liposomal bupivacaine plus 5mL bupivacaine (to be determined by the attending anesthesiologist). Primary outcome will be incidence of hemidiaphragmatic paralysis postoperative day 1 as measured by point of care (POCUS) ultrasound. Secondary outcomes include incidence of hemidiaphragmatic paralysis as measured by point of care ultrasound (POCUS) in the immediate postoperative period, postoperative day (POD) 1, POD2, and POD3 and noninvasive measures of pulmonary gas exchange at pre-op, post-op, POD1, POD2, and POD3. Additionally, the investigators will look at pain scores (scale of 0-10) and opioid consumption (in oral morphine equivalents) at previously defined time points listed above. Furthermore, the investigators will record known side effects of interscalene blocks including hoarseness and Horner's syndrome.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • English speaking 18-80 year old ASA 1-3 patients
  • Primary shoulder surgery
  • Must live within a 25 mile radius

排除标准

  • ASA 4 or 5
  • Revision shoulder surgery
  • Diagnosis of chronic pain
  • Daily chronic opioid use (over 3 months of continuous opioid use)
  • Inability to communicate pain scores or need for analgesia
  • Infection at the site of block placement
  • Age under 18 years old or greater than 80 years old
  • Pregnant women (as determined by point-of-care serum bHCG)
  • Intolerance/allergy to local anesthetics
  • Weight \<50 kg

研究组 & 干预措施

Continuous Perineural Catheter

Placement of preoperative continuous perineural catheter using 25 milliliters (mL) 0.5% ropivacaine with 1:400,000k ropivacaine for initial block and 0.2% ropivacaine for continuous infusion.

干预措施: Ultrasound (Diagnostic Test)

Continuous Perineural Catheter

Placement of preoperative continuous perineural catheter using 25 milliliters (mL) 0.5% ropivacaine with 1:400,000k ropivacaine for initial block and 0.2% ropivacaine for continuous infusion.

干预措施: Ropivacaine (Drug)

Continuous Perineural Catheter

Placement of preoperative continuous perineural catheter using 25 milliliters (mL) 0.5% ropivacaine with 1:400,000k ropivacaine for initial block and 0.2% ropivacaine for continuous infusion.

干预措施: MediPines AGM100 Advanced Respiratory Monitoring System (Device)

10 mL Liposomal Bupivacaine Single Shot

Placement of preoperative single shot using 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine

干预措施: Ultrasound (Diagnostic Test)

10 mL Liposomal Bupivacaine Single Shot

Placement of preoperative single shot using 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine

干预措施: Bupivacaine (Drug)

10 mL Liposomal Bupivacaine Single Shot

Placement of preoperative single shot using 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine

干预措施: MediPines AGM100 Advanced Respiratory Monitoring System (Device)

20 mL Liposomal Bupivacaine Single Shot

Placement of preoperative single shot using 20mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine

干预措施: Ultrasound (Diagnostic Test)

20 mL Liposomal Bupivacaine Single Shot

Placement of preoperative single shot using 20mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine

干预措施: Bupivacaine (Drug)

20 mL Liposomal Bupivacaine Single Shot

Placement of preoperative single shot using 20mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine

干预措施: MediPines AGM100 Advanced Respiratory Monitoring System (Device)

结局指标

主要结局

Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1

时间窗: 24 hours

Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis POD1

次要结局

  • Noninvasive pulmonary measures of gas exchange(up to 72 hours)
  • Pain scores(up to 72 hours)
  • Opioid consumption(up to 72 hours)
  • Hoarseness(up to 72 hours)
  • Hemidiaphragmatic paralysis - ipsilateral - PACU, POD2, POD3(up to 72 hours)
  • Horner's Syndrome(up to 72 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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