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临床试验/NCT05222334
NCT05222334Unknown不适用

Perioperative Respiratory and Analgesic Effects of Ultrasound-Guided Extrafascial Versus Intrafascial Interscalene Brachial Plexus Block in Patients Undergoing Shoulder Arthroscopy

Tanta University0 个研究点目标入组 50 人开始时间: 2022年2月1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
入组人数
50
主要终点
Incidence of diaphragmatic excursion reduction after interscalene block

研究概览

简要总结

The aim of the study is to compare the diaphragmatic excursion and postoperative analgesia in the extrafascial versus intrafascial Interscalene brachial plexus block in patients undergoing shoulder arthroscopy.

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
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients of both sexes aged (21-60years) with American Society of Anesthesiologists (ASA) physical status I/II scheduled for shoulder arthroscopy

排除标准

  • Patient refusal.
  • Pre-existing (obstructive or restrictive) pulmonary disease.
  • Bleeding disorders (coagulopathy).
  • Mental dysfunction.
  • History of allergy to local anesthetics.
  • Body mass index (BMI) >40

研究组 & 干预措施

Intrafascial interscalene brachial plexus block group

Experimental

The patients will receive 10 ml of 0.5% bupivacaine for intrafascial interscalene brachial plexus block group

干预措施: Intrafascial interscalene brachial plexus block (Procedure)

Intrafascial interscalene brachial plexus block group

Experimental

The patients will receive 10 ml of 0.5% bupivacaine for intrafascial interscalene brachial plexus block group

干预措施: Bupivacaine (Drug)

Extrafascial interscalene brachial plexus block group

Experimental

The patients will receive 10 ml of 0.5% bupivacaine for extrafascial interscalene brachial plexus block group

干预措施: Extrafascial interscalene brachial plexus block group (Procedure)

Extrafascial interscalene brachial plexus block group

Experimental

The patients will receive 10 ml of 0.5% bupivacaine for extrafascial interscalene brachial plexus block group

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Incidence of diaphragmatic excursion reduction after interscalene block

时间窗: 30 min postoperative.

The diaphragmatic excursion will be measured before the procedure (pre-block), 30 min after the block, and postoperative in Post-Anesthesia Care Unit. Hemidiaphragmatic paresis is defined as hemi-diaphragmatic excursion reduction superior to 75% compared with the pre-procedure value.

次要结局

  • Efficacy of block (sensory)(30 minutes Postoperatively)
  • Forced expiratory volume in 1 second (FEV 1)(Intraoperatively or 30 minutes postoperatively)
  • Pain score using numerical rating scale (NRS)(24 hours Postoperative)
  • Total postoperative analgesic consumption(24 hours Postoperative)
  • Peak expiratory flow (PEF)(Intraoperatively or 30 minutes postoperatively)
  • Efficacy of block (Motor)(30 minutes Postoperatively)

研究者

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

Radwa Emad Eissa

Assistant lecturer

Tanta University

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