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临床试验/NCT04356521
NCT04356521已完成不适用

Lateral Sagittal Versus Costoclavicular Approach for Ultrasound-Guided Infraclavicular Brachial Plexus Block: Comparison of Block Dynamics and Patient Comfort

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2020年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
109
试验地点
1
主要终点
Start time of the nervous block

研究概览

简要总结

An ultrasound-guided infraclavicular block performed with the costoclavicular (CC) approach and the lateral sagittal (LS) approach will be compared in patients scheduled for forearm and hand surgery.

详细描述

The CC approach is a recently introduced infraclavicular approach that targets three cords (medial, lateral and posterior) located lateral to the axillary artery in the costoclavicular space. Cords in this space are located more superficially than with the classical approach at the lateral infraclavicular fossa and are clustered but maintain a consistent anatomical relationship with each other.

Patients will be divided into two groups:

Group LS: Ultrasound-guided infraclavicular block - lateral sagittal approach (20 ml 0.5% bupivacaine)

Group CC: Ultrasound-guided infraclavicular block - costoclavicular approach (20 ml 0.5% bupivacaine)

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

入选标准

  • •Age 18 years to 65 years
  • •Patients scheduled for elective forearm and hand surgeries
  • •Patients with American Society of Anesthesiologists (ASA) 1-3

排除标准

  • •Patients not consenting/unwilling to participate
  • •Age <18 years or >65 years
  • •Patients with ASA 4
  • •Obesity (BMI >30 kg/m2)
  • •Regional anesthesia contraindicated (thrombocytopenia, infection at injection site)
  • •Severe renal, cardiac, or hepatic disease
  • •History of hypersensitivity or allergy to local anesthetics
  • •History of opioid or steroid use for more than 4 weeks
  • •History of psychiatric disorders
  • •Analgesic treatment in the last 48 hours preoperatively
  • •Operations lasting less than 60 minutes and more than 180 minutes
  • •Patients who converted to general anesthesia

研究组 & 干预措施

Group LS

Active Comparator

Ultrasound-guided infraclavicular block - lateral sagittal approach (20 ml 0.5% bupivacaine)

干预措施: Lateral Sagittal Approach (Procedure)

Group CC

Active Comparator

Ultrasound-guided infraclavicular block - costoclavicular approach (20 ml 0.5% bupivacaine)

干预措施: Costoclavicular Approach (Procedure)

结局指标

主要结局

Start time of the nervous block

时间窗: 45 minutes after the block procedure

Time from the local injection to when a pin-prick test yields no response in at least 1 of 3 cords in the extremity on which the operation is being performed.

Duration of start of motor block

时间窗: 45 minutes after the block procedure

Time from when a Lovett score of 5 is seen in at least 1 of 3 cords in the patient extremity on which the operation is being performed, following local anesthetic injection. Lovett rating scale: 6 = normal muscle strength, 5 = slightly decreased muscle strength, 4 = significantly decreased muscle strength, 3 = slight loss of movement, 2 = significant loss of movement, 1 = near total loss of movement, and 0 = total paralysis. Motor block cord myotomes will be evaluated as medial cord (thumb adduction = ulnar nerve), lateral cord (elbow flexion = mucocutaneous nerve), and posterior cord (wrist extension = radial nerve).

Performance time of the operator

时间窗: During the block procedure

Time elapsed from when the needle enters the skin after an optimal view is obtained on ultrasound until the block needle exits the skin after the procedure is completed.

次要结局

  • Time of sensory block(Postoperative Day 1)
  • Time of first analgesic request(Postoperative Day 1)
  • Surgeon Satisfaction(Postoperative Day 1)
  • Time of motor block(Postoperative Day 1)
  • Number of needle redirections(During the block procedure)
  • Number of patients who required a rescue block(45 minutes after the block procedure)
  • Patient Satisfaction(Postoperative Day 1)
  • Number of needle attempts(During the block procedure)

研究者

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

BURHAN DOST

Assistant Professor

Ondokuz Mayıs University

研究点 (1)

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