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临床试验/NCT07754357
NCT07754357Enrolling By Invitation不适用

Ultrasound-Guided T2 Erector Spinae Plane Block Versus Intercostobrachial Block as Adjunct to Supraclavicular Brachial Plexus Block in AV Fistula Surgery.

Fatma Hatem Mokhtar1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2026年7月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
110
试验地点
1
主要终点
Proportion of patients achieving complete sensory blockade during AVF superficialization

研究概览

简要总结

This study aims to determine whether ultrasound guided ESP block at 2nd thoracic vertebrae is non inferior to ultrasound guided ICBN block as adjunct to supraclavicular brachial plexus block in achieving complete sensory blockade of the medial upper arm during AVF superficialization

详细描述

Arteriovenous fistula (AVF) superficialization is an essential procedure for patients with end-stage renal disease . The supraclavicular brachial plexus block is commonly used for upper extremity surgeries .Because the ICBN originates from the T2 nerve root below the C5-T1 nerve roots comprising the brachial plexus, brachial plexus blocks are ideally supplemented with an ICBN infiltration block for medial upper arm coverage.The ICBB requires precise ultrasound guidance to target the ICBN, which is small and variably located, making it technically challenging and time-intensive.

ESP block at T2 level can provide broad coverage, ease of Performance, superficial injection and requiring less technical expertise compared to the ICBB .

The patients are randomly allocated into 2 groups :

  1. Erector spinae plane block group (Group ESP): will receive 10 ml of 0.5% bupivacaine injected into the erector spinae plane at T2 level under ultrasound guidance.
  2. Intercostobrachial block group (Group ICBB): will receive 10 ml of 0.5% bupivacaine injected around intercostobrachial nerve under ultrasound guidance. • Standard Supraclavicular Brachial plexus Block will be performed for all patients using 20 ml of 0.5% bupivacaine under ultrasound guidance.

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 (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •• Adults scheduled for upper extremity surgeries under regional anesthesia.
  • •Age: 18-65 years.
  • •American society of Anesthesiologists (ASA) III.
  • •Body Mass Index (BMI) < 35 kg/m².

排除标准

  • ••Allergy to local anesthetics.
  • •Coagulopathy or infection at injection sites.
  • •Pre-existing neuropathy or significant psychiatric disorders.
  • •Pregnant or lactating women.

研究组 & 干预措施

Ultrasound Guided Intercostobrachial Nerve Block

Active Comparator
  1. Position: patient supine with arm abducted.
  2. Ultrasound setup: High frequency probe positioned at upper axillary region.
  3. Technique: Needle will be advanced into subcutaneous tissue, in-plane to target intercostobrachial nerve near axillary artery.
  4. Drug: 10 ml of 0.5% bupivacaine.

干预措施: Ultrasound Guided Intercostobrachial Nerve Block (Procedure)

Ultrasound Guided Erector Spinae Plane Block at T2 level

Active Comparator
  1. Position: patient sitting or in lateral decubitus.
  2. Ultrasound setup: High frequency linear transducer will be placed in a parasagittal 2-3 cm lateral to spinous process at T2 level, erector spinae muscles will be identified superficial to the tip of T2 transverse process, patient's skin anesthetized with 3 ml of 2 % lidocaine subcutaneously, the tip of the 22- gauge 80-mm block needle (Sonoplex, Pajunk Medical, Geisingen, Germany) needle will be placed into the facial plane on the deep (anterior) aspect of erector spinae muscle. location of needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process then 10 ml of 0.5% bupivacaine will be injected into the facial plane that will be confirmed by visible hydrodissection .

干预措施: Ultrasound Guided Erector Spinae Plane Block at T2 level (Procedure)

结局指标

主要结局

Proportion of patients achieving complete sensory blockade during AVF superficialization

时间窗: baseline then at 15,30,60,120 minutes intraoperative assessment for vital signs and sensory blockade

No discomfort and no need for sedation or conversion to general anesthesia

次要结局

  • Time to achieve complete sensory blockade.(Time for complete sensory blockade in minutes within 30 minutes)
  • Patient's satisfaction (assessed using Likert scale).(At the first 24 hours)
  • Total opioid consumption in 24 hours(in the first 24 hours)
  • The visual analog scale(VAS)(in the first 12 hours)

研究者

发起方
Fatma Hatem Mokhtar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fatma Hatem Mokhtar

Resident doctor of anesthesia,ICU&pain management

Aswan University Hospital

研究点 (1)

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