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临床试验/NCT06953947
NCT06953947已完成不适用

A Comparison Between Interscalene and Costoclavicular Blocks for Pain Relief After Shoulder Surgery

Sakarya University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2022年10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
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
Postoperative Pain Measurement

研究概览

简要总结

AIM: Shoulder surgeries are among the most painful surgical procedures in orthopedic practice. Interscalene brachial plexus block, although the most commonly utilized regional anesthesia technique for alleviating pain following shoulder surgery, may result in complications such as hemidiaphragmatic paresis, hoarseness. More distal blocks along the brachial plexus may provide postoperative analgesia while potentially having less effect on respiratory functions. The aim of this study is to determine whether there are differences in postoperative pain scores and opioid consumption between interscalene block (ISB) and costoclavicular brachial plexus block (CCB).

MATERIALS AND METHODS: Following ethical approval, all eligible patients undergoing for shoulder surgery under general anesthesia between 01.11.2022 and 01.11.2023 will be enrolled and to be divided into two groups following written informed consent, with one group receiving ISB and the other group receiving CCB. A blinded researcher will record pain scores at postoperative 0.5, 1, 6, 12, 18, and 24 hours. Demographic data of patients, postoperative opioid consumption, time to first analgesic request, rescue analgesic requirements, adverse effects and hemodynamic parameters will be compared statistically.

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)

盲法说明

A blinded researcher recorded pain scores at postoperative 0.5, 1, 6, 12, 18, and 24 hours

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing unilateral shoulder surgery
  • •ASA (American Society of Anesthesiology) class I, II and III patients

排除标准

  • •Coagulopathy
  • •Chronic Pulmoner Disease
  • •Hypersensitivity to local anesthetics
  • •Ipsilateral neurological deficits
  • •Non-communicative patients

研究组 & 干预措施

Group CCB

Experimental

The group of patients which received costoclavicular block

干预措施: Costoclavicular block (Drug)

Group ISB

Experimental

The group of patients which received interscalene block

干预措施: Interscalene block (Procedure)

Group ISB

Experimental

The group of patients which received interscalene block

干预措施: Interscalene Nerve Block (Drug)

结局指标

主要结局

Postoperative Pain Measurement

时间窗: Measured at Postoperative 0.5, 1, 6, 12, 18, and 24 hours

The pain measurements of the patients after surgery which evaluated with visual analogue scale (VAS), ranging from 0 to 10 while 0 describes no pain at all and 10 describes the most severe pain a person can experience.

次要结局

  • Postoperative Opioid Consumption(Postoperative 24 hours.)
  • Time to first analgesic request(Postoperative 24 hours)
  • Rescue analgesic requirements(Postoperative 24 hours)
  • Adverse effects(Postoperative 24 hours)

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammed Halit Tekeci, MD

Anesthesiology and Reanimation Specialist, M.D.

Sakarya University

研究点 (1)

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