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临床试验/NCT04786756
NCT04786756已完成不适用

Comparison of Ultrasound-Guided Lateral and Medial Approaches to Costoclavicular Brachial Plexus Block in Pediatric Patients Undergoing Unilateral Upper Exremity Surgery: A Randomized Controlled Double-Blinded Study

Istanbul University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2020年1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
入组人数
55
试验地点
1
主要终点
Number of needle maneuvers

研究概览

简要总结

In upper extremity surgeries, the brachial plexus block can be performed with different techniques at various levels depending on the proximal and distal level of the surgery. In this study, we aim to compare the different approaches of US guided costoclavicular technique. Lateral approache is more common for the costoclavicular block area. However, more needle maneuvers are needed especially in pediatric patients because of the coracoid process. Medial approach is recommended to overcome this problem. Thus demonstrate the safety of upper extremity blocks, which is an important part of multimodal analgesia, and to determine the most ideal technique in the pediatric patient group who will undergo upper extremity surgery.

During the block application, the US imaging time, the difficulty level of needle imaging, the number of maneuvers required to reach the target image, whether additional maneuvers are required according to the local anesthetic distribution, the success of the block and the duration of the surgery, the total application time of the block and the duration of general anesthesia will be recorded. Mean arterial pressure and heart rate will be recorded at 30-minute intervals during the surgery. Standardized for pediatric patients The FLACC and Wong-Baker pain scores will be followed first 24 hours after surgery. The patient will be examined for motor and sensation, and analgesic doses will be recorded if used. Time to first pain identification, duration of sleep, patient and surgeon satisfaction will be recorded.

详细描述

Peripheral nerve blocks; It is widely used in daily practice for anesthesia or as a part of multimodal analgesia in most surgical procedures. In upper extremity surgeries, the brachial plexus block can be performed with different techniques at various levels depending on the proximal and distal level of the surgery. In this study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients. In this study, we aim to compare the different approaches of US guided costoclavicular technique. Lateral approache is more common for the costoclavicular block area. However, more needle maneuvers are needed especially in pediatric patients because of the coracoid process. Medial approach is recommended to overcome this problem. Thus demonstrate the safety of upper extremity blocks, which is an important part of multimodal analgesia, and to determine the most ideal technique in the pediatric patient group who will undergo upper extremity surgery.

During the block application, the US imaging time, the difficulty level of needle imaging, the number of maneuvers required to reach the target image, whether additional maneuvers are required according to the local anesthetic distribution, the success of the block and the duration of the surgery, the total application time of the block and the duration of general anesthesia will be recorded. Mean arterial pressure and heart rate will be recorded at 30-minute intervals during the surgery. Standardized for pediatric patients The FLACC and Wong-Baker pain scores will be followed first 24 hours after surgery. The patient will be examined for motor and sensation, and analgesic doses will be recorded if used. Time to first pain identification, duration of sleep, patient and surgeon satisfaction will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Undergoing unilateral upper extremity surgery (distal midhumerus).
  • ASA(American Society of Anesthesiology) 1-3
  • Receiving family consent from the parents that they accept regional analgesia

排除标准

  • Parents refusal
  • Infection on the local anesthetic application area
  • Infection in the central nervous system
  • Coagulopathy
  • Brain tumors
  • Known allergy against local anesthetics
  • Anatomical difficulties
  • Syndromic patient

研究组 & 干预措施

Lateral Approach of Costoclavicular Block

Active Comparator

US-guided lateral approach costoclavicular block with 1 mg/kg Bupivacaine (%0,25)

干预措施: Bupivacaine 0.25% Injectable Solution (Drug)

Medial Approach of Costoclavicular Block

Active Comparator

US-guided medial approach costoclavicular block with 1 mg/kg Bupivacaine (%0,25)

干预措施: Bupivacaine 0.25% Injectable Solution (Drug)

结局指标

主要结局

Number of needle maneuvers

时间窗: Up to 15 minutes

Number of needle maneuvers according to local anesthetic distribution

次要结局

  • Face, Legs Activity, Cry, Consolability (FLACC) scores(Up to 24 hours)
  • Wong Baker FACES scale(Up to 24 hours)
  • Patient number requiring additional analgesix(Up to 24 hours)
  • Sleeping duration(Up to 24 hours)
  • Family satisfaction(Up to 24 hours)
  • Total procedure difficulty according to the anesthesiologist(Up to 15 minutes)
  • Motor blockade physical examination(Up to 24 hours)
  • Sensorial blockade physical examination(Up to 24 hours)
  • Time to first pain(Up to 24 hours)
  • Surgeon satisfaction(Up to 24 hours)
  • Ideal USG guided brachial plexus cords visualization/needle pathway planning time(Up to 15 minutes)
  • Needle tip and shaft imaging visualization(Up to 15 minutes)
  • Requirement of additional needle maneuver due to insufficient local anesthetic distribution(Up to 15 minutes)
  • Patient number requiring rescue analgesics(Intraoperative 2-4 hours)
  • Complications/side effects(Up to 24 hours)

研究者

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

Meltem Savran Karadeniz

Associate Professor

Istanbul University

研究点 (1)

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