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临床试验/NCT05881473
NCT05881473已完成不适用

Ultrasound-guided Clavipectoral Fascial Plane Block Versus Ultrasound-guided Superficial Cervical Plexus Block in Patients Undergoing Fracture Clavicle Operation

Ain Shams University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年6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
入组人数
84
试验地点
1
主要终点
visual analogue score (VAS score) post operative

研究概览

简要总结

Ultrasound-guided Clavipectoral fascial plane block versus ultrasound-guided superficial Cervical plexus block in patients undergoing fracture clavicle operation

详细描述

The clavipectoral fascial plane block (CPB) is a novel regional anesthesia technique that has been utilized for clavicular fracture surgery. It has been hypothesized that the CPB is an effective regional anesthesia technique for peri-operative analgesia since the terminal branches of many of the sensory nerves like suprascapular, subclavian, lateral pectoral, and long thoracic nerves pass through the plane between the clavipectoral fascia and the clavicle itself.

The ultrasound-guided superficial cervical plexus (SCP) block may be useful for providers in emergency care settings who care for patients with ear, neck, and clavicular region injuries, including clavicle fractures and acromioclavicular dislocations. The SCP originates from the anterior rami of the C1-C4 spinal nerves and gives rise to 4 terminal branches (greater auricular, lesser occipital, transverse cervical, and suprascapular nerves) that provide sensory innervation to the skin and superficial structures of the anterolateral neck and sections of the ear and shoulder.

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, Care Provider)

入排标准

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

入选标准

  • •Age from 21 to 60 years
  • •Both gender
  • •Isolated fracture clavicle.
  • •ASA classification 1 & 2

排除标准

  • •Polytrauma patients with multiple fractures.
  • •Hemodynamically unstable patients.
  • •Patients with infection at the injection site.
  • •Refusal of patients.
  • •Patients with disturbed anatomical plane.
  • •Patients with a known history of allergy to local anesthetic will be used.

研究组 & 干预措施

Group cervical: (control group):

Other

This group includes (40) patients. The patient will be placed in a supine position with the head turned to the contralateral side for adequate exposure of the neck and the upper chest. A linear high-frequency ultrasound probe (6-13 MHz, Sonosite) will be placed at the lateral side of the neck over the midpoint of the sterno-cleido-mastoid muscle at the level of the cricoid cartilage, which corresponds with the C6 transverse process. Once the muscle is identified, the probe will then be moved posteriorly until the posterior tapering edge of the muscle is identified where the interscalene groove between the anterior and middle scalene muscles is identified. Then, the superficial cervical plexus (SCP) will be visualized. A five-cm block needle will then be introduced from lateral to medial using the posterior-in-plane technique until its tip is placed near the SCP above the prevertebral fascia.10 mL of 0.5% Bupivacaine will be deposited.

干预措施: pain assessment after clavicular fracture repair (Diagnostic Test)

Group clavipectoral: (study group)

Other

This group includes (40) patients will have medial and lateral clavipectoral (CPB) block ultrasound guided using 20 ml Bupivacaine 0.5% for medial and lateral block equally after induction of general anesthesia.

The patient will be placed in a supine position with the head turned to the contralateral side, and the shoulder will be padded with a small pillow. a 6- to 13-MHz linear array probe will be used for regional anesthesia. During CPB, an ultrasound probe will be placed on both the inner and outer one-third of the anterior surface of the clavicle. Using the in-plane technique, a 22-gauge needle will be inserted and advanced into the space between the periosteum of the clavicle and clavipectoral fascia in a caudal to cephalad direction, and a total of 20 mL of 0.5% Bupivacaine will be equally injected medially and laterally

干预措施: pain assessment after clavicular fracture repair (Diagnostic Test)

结局指标

主要结局

visual analogue score (VAS score) post operative

时间窗: starting at the recovery room then every 2 hours for 8 hours post operatively

change in visual analogue score (VAS score) to assess pain post operative described as 10= the sever pain and zero = no pain

次要结局

  • hemodynamics(every 2 hours for 8 hours)

研究者

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

Amr Gaber

lecturer

Ain Shams University

研究点 (1)

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