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临床试验/NCT03453086
NCT03453086已完成不适用

A Randomized Controlled Study Comparing Thoracic Paravertebral Block to Serratus Anterior Plane Block in Breast Surgery

Cairo University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月4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
30
试验地点
2
主要终点
First pain medication request

研究概览

简要总结

The investigators hypothesize that the analgesic efficacy of ultrasound-guided serratus anterior plane block will provide better analgesia with fewer complications in comparison to ultrasound guided thoracic paravertebral block

详细描述

•The blocks techniques:

  • Group I: Thoracic paravertebral block group (TPVB group n=15) These patients will receive single ipsilateral ultrasound-guided thoracic paravertebral block. TPVB will be performed with the patient in the sitting position at the level of the 4th thoracic vertebra under complete aseptic precaution with the probe in a vertical position approximately 2.5-3 cm lateral to the midline. The midpoint of the transducer is to be placed in a longitudinal paramedian plane between two transverse processes. Both transverse processes should be visualized, with the superior costo-transverse ligament and the pleura visible in between .An 18-20 gauge Tuohy needle will be introduced in a cephalad direction. The tip of the needle will be advanced under direct visualization until it pierces the superior costo-transverse ligament. the investigators will inject small aliquots of normal saline intermittently as the investigators advance the needle to confirm the position of the tip. When the needle tip is located immediately above the pleura, the needle is aspirated to confirm the absence of blood or air. After this, 15-20 cc of bupivacaine 0.25% will be injected. Spread of local anaesthetic with depression of the pleura will be clearly visualized. The extent of local anaesthetic spread should be evaluated by moving the ultrasound probe superiorly and inferiorly.
  • Group II :Serratus anterior plane block group (SAP group n= 15) These patients will receive serratus anterior plane block. The SAP block will be performed while the patient is in the supine position by using a linear US probe of high frequency (6-13 MHz) after sheathing. The probe will be placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The ribs will be counted inferiorly and laterally, until the 5th rib is identified in the midaxillary line. The latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscles (deep and inferior) will be then easily identifiable by ultrasound overlying the fifth rib. The needle (Stimuplex, B Braun, Germany 22-G, 50-mm) will be introduced in-plane with respect to the ultrasound probe from supero-anterior to postero-inferior. Under continuous ultrasound guidance, the investigators will inject 20 cc of bupivacaine 0.25%. The sensory level will be tested with pin prick and ice pack before induction of general anesthesia

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

盲法说明

•Patients will be randomly allocated to one of the two groups by sealed closed envelop technique

入排标准

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

入选标准

  • •Female patients
  • •Breast surgery with or without axillary clearance.
  • •Age from 20 to 60 years.
  • •ASA I, II, III.

排除标准

  • •Major reconstructive breast surgery.
  • •Age younger than 20 or older than 60 years.
  • •Hypersensitivity to any drug to be used.

研究组 & 干预措施

Group I:

Active Comparator

These patients will receive single ipsilateral Ultrasound TPVB which performed with the patient in the sitting position at the level of the T4 with the probe in a vertical position 2.5-3 cm lateral to the midline. The midpoint of the transducer is to be placed in a longitudinal paramedian plane between two transverse processes which visualized with the superior costo-transverse ligament and the pleura visible in between . After this, 15-20 cc of bupivacaine 0.25% will be injected

干预措施: Thoracic paravertebral block(TPVB) group (Procedure)

Group II :

Active Comparator

These patients will receive serratus anterior plane block. The block will be performed while the patient is in the supine position by using a linear Ultrasound probe of high frequency (6-13 MHz) after sheathing. The probe will be placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The ribs will be counted inferiorly and laterally, until the 5th rib is identified in the midaxillary line. The latissimus dorsi (superficial and posterior) , teres major (superior) and serratus muscles (deep and inferior) will be then easily identifiable by U/S overlying the fifth rib.

干预措施: Thoracic paravertebral block(TPVB) group (Procedure)

结局指标

主要结局

First pain medication request

时间窗: 24 hours

Time to the first pain medication request till application of the block

次要结局

  • Time of pain onset(24 hours)
  • Hemodynamics (ABP)(24 hours)
  • Hemodynamics (heart rate)(24 hours)
  • Nausea and vomiting(24 hours)

研究者

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

Ahmed Abdalla

Assistant Professor of Anesthesia &I.C.U and Pain Clinic

Cairo University

研究点 (2)

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