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临床试验/NCT07386470
NCT07386470已完成不适用

Effect of Costoclavicular Versus Lateral Sagittal Infraclavicular Block on Hemidiaphragmatic Function: A Randomized Clinical Study

Gazi University1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2022年10月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
1
主要终点
Diaphragmatic excursion

研究概览

简要总结

This randomized clinical study aims to compare the effects of two different ultrasound-guided infraclavicular brachial plexus block techniques-costoclavicular and lateral sagittal approaches-in patients undergoing forearm, wrist, or hand surgery.

The primary objective of the study is to evaluate and compare the incidence of hemidiaphragmatic dysfunction associated with these two block techniques. Secondary outcomes include sensory and motor block characteristics, postoperative pain scores, analgesic requirements, and potential block-related complications.

Eligible adult patients scheduled for elective forearm or hand surgery are randomly assigned to receive either a costoclavicular or a lateral sagittal infraclavicular nerve block using bupivacaine under ultrasound guidance. Standard general anesthesia and postoperative analgesia protocols are applied.

The results of this study are expected to provide evidence on the relative safety and efficacy of these two infraclavicular block approaches, particularly regarding diaphragmatic function, and to help guide anesthesiologists in selecting the most appropriate regional anesthesia technique for upper extremity surgery.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-80 years
  • ASA physical status I-III
  • Scheduled for forearm, wrist, or hand surgery
  • Planned infraclavicular brachial plexus block

排除标准

  • Refusal of regional anesthesia
  • Known allergy to local anesthetics
  • Infection at the block site
  • Pre-existing neurological deficit in the operative limb
  • Severe pulmonary disease
  • Coagulopathy or sepsis
  • BMI > 40 kg/m²
  • Psychiatric disorders

研究组 & 干预措施

Costoclavicular infraclavicular block

Experimental

Ultrasound-guided costoclavicular infraclavicular brachial plexus block

干预措施: Ultrasound-guided Infraclavicular block (Procedure)

Lateral sagittal infraclavicular block

Active Comparator

Ultrasound-guided lateral sagittal infraclavicular brachial plexus block

干预措施: Ultrasound-guided Infraclavicular block (Procedure)

结局指标

主要结局

Diaphragmatic excursion

时间窗: Baseline(pre-block) and 30 minutes after block performance.

Diaphragmatic excursion measured by ultrasound during normal and deep breathing to asses the effect of costoclavicular and lateral sagittal infraclavicular block techniques.

次要结局

  • Sensory and motor block onset time(Within the first 30 minutes after block performance.)
  • Time to first postoperative analgesic requirement(Within the first 24 hours postoperatively.)

研究者

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

İrfan GUNGOR

MD, Professor

Gazi University

研究点 (1)

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