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临床试验/NCT02074397
NCT02074397已完成不适用

Distant Extrafascial Injection vs Subfascial Injection for Interscalene Block: Acute Pain Outcomes and Rates of Complications

Centre Hospitalier Universitaire Vaudois2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年2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
40
试验地点
2
主要终点
Rate of hemidiaphragmatic paresis, assessed with the ultrasound

研究概览

简要总结

The objective of this randomized controlled trial is to compare the analgesic efficacy and the safety profile between two techniques of injection for the interscalene block. The interscalene block consists of injecting local anesthetic around the cervical roots of the brachial plexus and allows analgesia after shoulder surgery.

Stated differently, the dual objective of that study is:

  1. to confirm that an injection at a distance of 4 mm away from the lateral sheath of the plexus (distal injection) provides similar analgesia as a classical injection within the plexus (subfascial injection);
  2. to demonstrate that a distant extrafascial injection produces less respiratory complications than a subfascial injection, defined as hemidiaphragmatic paresis.

详细描述

This is a prospective randomized controlled double-blinded trial on patients undergoing shoulder surgery (shoulder arthroscopy or open shoulder surgery), aged between 18 and 85 years old.

The exclusion criteria will be contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area); existing neurological deficit in the area to be blocked; severe respiratory disease; inability to understand the informed consent and patient refusal.

Prior to the procedure, all patients will be fully informed about the risks and benefits of participating in the study and written informed consent will be obtained.

Interscalene brachial plexus block will be performed with the patient lying lateral on the non-operative side, following our routine clinical practice, with twenty milliliters of local anesthetic containing bupivacaine 0.5% with 1:200,000 epinephrine. For patients in the subfascial injection group, the needle tip will be positioned lateral to the brachial plexus at a distance of 4 mm, measured with a caliper.

Block assessment and definition of a successful block Evaluation of sensory and motor blockades will be performed by a blinded research assistant every 5 min, for a total of 30 min, after local anesthetic (LA) injection. Sensory block and motor blockades will be tested in the C4, C5, C6, C7, and C8 dermatomes using a blunt tip needle pinprick test and muscular testing. A successful block will be defined as complete sensory and motor blockade in the distribution of the C5 and C6 nerve roots within 30 minutes of performing the ISB. In cases of a failed block, the ISB will be repeated at the discretion of the attending anesthesiologist and these patients will be excluded from the intraoperative and postoperative secondary outcome analyses.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA (American Society of Anesthesiology) physical status I-II
  • 18 - 85 years of age
  • surgery less than 3 hours

排除标准

  • indication for continuous interscalene block (catheters)
  • contraindications for brachial plexus block (eg allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
  • existing neurological deficit in the area to be blocked
  • history of neck surgery or radiotherapy

结局指标

主要结局

Rate of hemidiaphragmatic paresis, assessed with the ultrasound

时间窗: 30 minutes after block procedure

Rate of success block defined as complete motor and sensory block on C5-C6 territories

时间窗: 30 minutes after block procedure

次要结局

未报告次要终点

研究者

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

Eric Albrecht

MD; program director, regional aneshesia

Centre Hospitalier Universitaire Vaudois

研究点 (2)

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