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临床试验/NCT05325372
NCT05325372已完成不适用

A Comparative Study Between the Ultrasound-guided Infraclavicular Block and Axillary Block for Assessment of Motor Power Degree and Duration Using Handgrip Dynamometer in Patients Undergoing Minor Hand Surgery. A Randomized Control Trial

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
2
主要终点
Postoperative change in handgrip strength in the operative limb

研究概览

简要总结

Hand Surgery is surgery of the hand, the wrist, and the peripheral nerves of the upper limb. Many different types of surgeries can be performed on the hand, depending on the underlying cause of the problem such as Closed reduction and fixation, Tendon repair, Skin grafts, Skin flaps, Carpal Tunnel Release, and ganglion removal. Hand surgery is usually associated with marked postoperative pain. Ultrasound-guided regional anesthesia is usually performed in patients undergoing hand surgery.

This study aims to compare Ultrasound-guided infraclavicular block and axillary block and assess the degree of motor power and duration by testing hand grip strength using a hydraulic hand dynamometer in patients undergoing hand surgery.

Objectives:

To determine the degree of a motor block using a hydraulic hand dynamometer. To Estimate time needed to regain full motor activity. To identify whether ultrasound-guided axillary block may preserve motor function to a greater extent than infraclavicular blocks.

详细描述

This randomized control trial is designed to include (52) patients ASA physical status I, II patients ranging from(18) to(60)years old scheduled for hand surgery

Patients meeting the inclusion criteria will be randomly assigned to receive either:

Group I: axillary block technique (n=26) (group A) GroupII: infraclavicular block technique( n=26)(group B) Anesthesia management After arrival to the anesthetic room, An 18-gauge intravenous cannula will be placed at the forearm contralateral to the operated arm, standard monitoring will be used (non-invasive arterial blood pressure, ECG, pulse oximetry) while performing the block and throughout the surgical procedure. Premedication will be given intravenously in the form of 0.03 mg/kg midazolam. 1 g paracetamol iv will be given for all patients Under aseptic conditions, a preliminary scan will be performed using siemens acuson x 300 ultrasound with 8-14 MHz linear transducer. A 50-mm block needle 22 gauge will be used. (SonoPlex Stim Cannula, Germany) All blocks will be given by one researcher using 20 ml of drug 0.25% bupivacaine (10 ml 0.5% bupivacaine + 10 ml normal saline).

Axillary block

Patients in group A will be placed in the supine position with the arm to be blocked abducted and externally rotated. After sterilization of the axilla, the Ultrasound probe with a linear high frequency (8-14 MHZ) transducer will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identify the hyperechoic median, ulnar, and radial nerves in relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles. Lidocaine 1% was infiltrated subcutaneously 1 cm lateral to the probe. The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked. A local anesthetic will be administered adjacent to each of the four nerves (at least 5 ml for each).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Randomization will be done by computer-generated numbers and concealed by serially numbered, opaque, and sealed envelopes. The details of the series will be unknown to the investigators and the group assignment will be kept in a set of sealed envelopes each bearing only the case number on the outside.

This study will be performed by 3 anesthetists; one anesthetist who is experienced in performing the blocks will be allocated to perform either the axillary or infraclavicular block according to a computer-generated sequence of random numbers and sealed envelope, and the other two anesthetists will be blinded to the technique performed, and they will monitor the patients intra and postoperatively. Assessment of brachial plexus blockade will be carried out every 10 mins until 30 min by one of these two blinded observers. The infraclavicular and axillary areas will be covered to maintain the blinding of investigators.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Gender both males and females
  • ASA Class I, II
  • Age 18-60 years
  • Patients undergoing minor hand surgery (skin graft, Carpal Tunnel Release, ganglion removal, and lipoma ) expected surgical time of more than 15 min and less than one hour.

排除标准

  • Allergy to local anesthetic
  • Infection of the skin at the site of block.
  • Bilateral surgery, neck and clavicle deformities, existing neurological disease chronic pain diagnosis, pre-existing nerve damage, muscle injuries, and tendon injury.
  • Coagulopathy, previous surgery on the operative limb, inability to comprehend study-related procedures, and clinically significant cognitive impairment.

结局指标

主要结局

Postoperative change in handgrip strength in the operative limb

时间窗: it will be measured at 90 min from the block

Postoperative change in handgrip strength in the operative limb as a percent reduction of preoperative baseline strength at 90 min from the block (%)

次要结局

  • Block related complications(it will be measured in the first 24 hours postoperative)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed nabih youssef

Lecturer of anesthesia (principal investigator)

Kasr El Aini Hospital

研究点 (2)

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