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临床试验/NCT03487874
NCT03487874已完成不适用

Efficacy of the 8th Cervical Nerve Root Block During Interscalene Brachial Plexus Block for Arthroscopic Shoulder Surgery: Prospective Randomized Controlled Study

Daegu Catholic University Medical Center1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2018年4月4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
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
Pain intensity upon the introduction of a posterior portal

研究概览

简要总结

This study evaluates the effects of selective 8th cervical nerve root block during interscalene brachial plexus block on the relief of pain intensity upon the introduction of a posterior portal during arthroscopic shoulder surgery. The 5th to 7th cervical nerve roots will be blocked in half of participants, while the 5th to 8th cervical nerve roots will be blocked in the other half.

详细描述

By blocking only the 5th to 7th cervical nerve blocks, conventional interscalene brachial plexus block spares the 8th cervical and 1st thoracic dermatomes which innervate the posterior aspect of the shoulder. To visualize the shoulder joint space during shoulder arthroscopic surgery, the introduction of a posterior portal is essential. However, conventional interscalene brachial plexus block cannot effectively relieve the pain caused by its insertion due to sparing of the 8th cervical and 1st thoracic dermatomes. The addition of the 8th cervical nerve root block to conventional interscalene brachial plexus block decreases pain intensity upon the introduction of a posterior portal.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status 1 and 2
  • Arthroscopic shoulder surgery under interscalene brachial plexus block

排除标准

  • Patient refusal
  • Contralateral hemidiaphragmatic paralysis or paresis
  • Contralateral vocal cord palsy
  • Severe pulmonary restrictive disease
  • Coagulopathy
  • Allergy to local anesthetics or history of allergic shock
  • Difficulty communicating with medical personnel
  • Peripheral neuropathy or neurologic sequelae on the operative limb

研究组 & 干预措施

Interscalene block with C8 root block

Experimental

The 5th to 8th cervical nerve root block under ultrasound guidance using 25 to 30 ml of 0.75% ropivacaine

干预措施: Interscalene block with C8 root block (Procedure)

Interscalene block with C8 root block

Experimental

The 5th to 8th cervical nerve root block under ultrasound guidance using 25 to 30 ml of 0.75% ropivacaine

干预措施: 0.75% ropivacaine (Drug)

Conventional interscalene block

Active Comparator

The 5th to 7th cervical nerve root block under ultrasound guidance using 25 to 30 ml of 0.75% ropivacaine

干预措施: Conventional interscalene block (Procedure)

Conventional interscalene block

Active Comparator

The 5th to 7th cervical nerve root block under ultrasound guidance using 25 to 30 ml of 0.75% ropivacaine

干预措施: 0.75% ropivacaine (Drug)

结局指标

主要结局

Pain intensity upon the introduction of a posterior portal

时间窗: 50 minutes after interscalene block

0, 1, and 2 represent no pain, mild pain, and severe pain, respectively.

次要结局

  • Frequency of postoperative analgesic use(24 hours)
  • Motor blockade(30 minutes after interscalene block)
  • Pulmonary function test(Before interscalene block and 30 minutes after interscalene block)
  • Complications related with interscalene block(24 hours)
  • Postoperative hour when pain starts to be felt(24 hours)
  • Patient's satisfaction about surgical anesthesia and postoperative analgesia(24 hours)
  • Sensory blockade(30 minutes after interscalene block)
  • Ipsilateral hemidiaphragmatic blockade(Before interscalene block and 30 minutes after interscalene block)
  • Horner's syndrome(Before interscalene block and 30 minutes after interscalene block)
  • Dose of postoperative analgesic use(24 hours)
  • Conversion into general anesthesia(1 hour)
  • Numerical pain rating score between 6 and 12 hours after surgery(6 and 12 hours)
  • Worst numerical pain rating score(24 hours)
  • Dose of intraoperative analgesic use(2 hours)
  • Numerical pain rating score at admission to postanesthetic care unit(5 minutes)
  • Numerical pain rating score at discharge from postanesthetic care unit(30 minutes)
  • Numerical pain rating score 24 hours after surgery(24 hours)
  • Frequency of intraoperative analgesic use(2 hours)

研究者

发起方
Daegu Catholic University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

JongHae Kim

Associate Professor

Daegu Catholic University Medical Center

研究点 (1)

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