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临床试验/NCT05661253
NCT05661253招募中不适用

Ultrasound Guided Modified Versus Conventional Serratus Anterior Plane Block as a Preemptive Analgesia for Unilateral Video-Assisted Thoracoscopic Surgery

Zagazig University1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2022年12月2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
招募中
入组人数
99
试验地点
1
主要终点
tramadol consumption

研究概览

简要总结

comparing preemptive analgesia with ultrasound guided modified serratus anterior plane block versus ultrasound guided serratus anterior plane block

详细描述

comparing the quality of postoperative analgesia and opioid consumption in patients undergoing Video-Assisted Thoracoscopic Surgery when using preemptive analgesia with ultrasound guided modified serratus anterior plane block versus ultrasound guided serratus anterior plane block

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Patient consent.
  • both sex.
  • Age: 21-70 years old.
  • BMI: 18- 30 kg/m2
  • ASA: I and II.
  • Scheduled for elective unilateral Video-Assisted thoracoscopy under general anesthesia.

排除标准

  • History of allergy to the local anesthesia agents used in this study,
  • Skin lesion at needle insertion site,
  • Those receiving anticoagulant therapy or having bleeding disorders
  • Patients with history of chronic pain and taking analgesics,
  • Patients with sepsis and Significant cardiac, liver or renal diseases
  • Uncooperative patients or with psychiatric disorders.

研究组 & 干预措施

SAP block group

Active Comparator

After sterilization of the skin and draping, the high frequency linear probe of Sonosite M Turbo ultrasonography (FUJIFIM sonosite, Inc., Bothell, WA, USA) will be placed at the level of the midclavicular line in a sagittal plane. The second rib will be recognized at the axillary artery. The probe will be moved downward to count the ribs until the level of the fifth rib in the mid-axillary line. At this time, the latissimus dorsi muscle (lying superficial) and the serratus anterior muscle (lying deep) will be clearly visualized under ultrasound . Next, A 22-gauge, 80 mm needle (Stimuplex D, B-Braun, Germany) will be inserted in plane relative to the ultrasound probe between the latissimus dorsi and the serratus anterior muscle. After confirming negative aspiration of blood, 1 ml normal saline will be injected for hydro-dissection sign to verify the needle tip, then a volume of 25 ml 0.25% bupivacaine will be injected superficially to serratus anterior muscle. .

干预措施: 25 ml of bupivacaine 0.25% via serratus anterior block (Drug)

modified SAP block group

Active Comparator

The patient will be placed in the lateral decubitus position according to the selected site of surgical intervention. After sterilization of the skin and draping, the high frequency linear probe of Sonosite M Turbo ultrasonography ( FUJIFIM sonosite, Inc., Bothell, WA, USA) will be placed horizontally midway between tip of the scapula and posterior axillary line to identify the view of latissimus dorsi(lying superficial) and serratus anterior muscle(lying deep) over either the sixth or seventh rib. A 22-gauge, 80 mm needle (Stimuplex D, B-Braun, Germany) will be inserted in plane relative to the ultrasound probe from posteromedial to anterolateral direction toward posterior axillary line till reaching the interfacial plane between latissimus dorsi and serratus anterior muscle . After confirming negative aspiration of blood, 1 ml normal saline will be injected for hydro-dissection sign to verify the needle tip, then a volume of 25 ml 0.25% bupivacaine will be injected .

干预措施: 25 ml of bupivacaine 0.25% via modified serratus anterior palne block (Drug)

结局指标

主要结局

tramadol consumption

时间窗: at 24 hours postoperative

The amount of tramadol consumption at 24

次要结局

  • Time of performance(from ultrasound probe positioning till the end of the block procedure)
  • Patient satisfaction(at 24 hous post operative)
  • Time to first dose of rescue analgesia(during the first postoperative 24 hours)

研究者

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

Heba M Fathi

prof/Dr

Zagazig University

研究点 (1)

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