跳至主要内容
临床试验/NCT05809258
NCT05809258招募中不适用

Comparison of Efficacy of Ultrasound-Guided Supraclavicular and Axillary Block for Arterio-Venous Fistula Creation: An Observer-Blinded, Non-inferiority Randomized Controlled Trial

Sultan Qaboos University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年8月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Requirement of additional analgesics intraoperatively or block failure (conversion to general anaesthesia)

研究概览

简要总结

This study compares the analgesic efficacy of supraclavicular brachial plexus nerve block to axillary nerve block techniques in adults undergoing AV fistula creation. Both these techniques will be done under ultrasound guidance, using the same local anesthetic drug. 120 patients will be included in this study, 60 patients for each technique. This study will help us know better regional anesthesia techniques, the additional need for analgesia/anesthesia, and the recovery rate following either of the blocks for AV fistula surgery. An interim analysis will be done after recruiting 50% of cases (30 cases) in both arms.

详细描述

Introduction An AV fistula creation is generally performed at the antecubital fossa under regional anesthesia. General anesthesia is associated with increased cardiorespiratory complications in patients with end-stage renal disease. Thus, in such patients, RA, such as a brachial plexus block (BPB), is favored for AVF creation. In this study comparison between two well-established and frequently used approaches of brachial plexus block: supraclavicular and axillary, will be compared.

The supraclavicular block is one of several approaches used for the brachial plexus block. The block is performed at the level of the brachial plexus trunks, where almost the entire sensory, motor, and sympathetic innervation of the upper extremity is carried in just three nerve structures confined to a very small surface area. Indications for the supraclavicular block include elbow, forearm, and hand surgeries.

The axillary block technique is relatively easy to approach and simple to perform and may be associated with a lower risk of complications than supraclavicular BPB. The supraclavicular has a slightly wider area of coverage and a supposedly higher rate of complications compared to the axillary approach when performed with a traditional approach without ultrasound guidance. Using ultrasound should reduce the rate of complications for both blocks. No randomized control study has compared the efficacy of both blocks for AV Fistula creation with ultrasound guidance. This study aims to determine a better anesthesia technique for AV fistula creation in terms of anesthesia efficacy, complications, and recovery.

Method

Study type: Randomized, Controlled, observer-blinded non-inferiority trial, with two parallel arms.

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 (Investigator, Outcomes Assessor)

盲法说明

The investigator and assessor will be blinded. The block performer anaesthetist and the patient will know the technique.

入排标准

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

入选标准

  • Age >18 years old
  • Patients undergoing AV fistula creation in the antecubital fossa

排除标准

  • - Patient Refusal
  • Hemodynamically unstable patient
  • Local infection over the insertion site
  • Coagulopathy
  • Known allergy to Local Anaesthetic medications
  • Abnormal anatomy
  • Use of antiplatelet within 7 days of surgery

结局指标

主要结局

Requirement of additional analgesics intraoperatively or block failure (conversion to general anaesthesia)

时间窗: 20 minutes to 2 hours 30 minutes

Paracetamol 15 mg/kg or Fentanyl 0.5 mics/kg or local infiltration or change to General Anesthesia

次要结局

  • Time of motor recovery of block(up to 24 hours)
  • Rate of complications(up to 24 hours)

研究者

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

Dr Jyoti Burad

Senior specialist

Sultan Qaboos University

研究点 (2)

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