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临床试验/NCT04729868
NCT04729868已完成不适用

Ultrasound Guided Infraclavicular Brachial Plexus Block Using Levo-bupivacaine Alone or Combined With Dexmedetomidine for Hand and Forearm Surgeries

Aswan University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年4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
60
试验地点
1
主要终点
onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)

研究概览

简要总结

To evaluate the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries as regard:

Onset of sensory and motor blockade. Duration of sensory and motor blockade.

Analgesic pain scores using the verbal rating scale (VRS) for pain. Duration of analgesia postoperative complications.

详细描述

Technique for ultrasound guided infraclavicular brachial plexus block:

Preliminary scan

  • The patient is positioned supine with the arm abducted to 90°(or resting by their side if unable to do so).
  • The probe is placed immediately medial to the coracoid process in the parasagittal plane.
  • Identify the pectoralis major and minor muscles superficially and the axillary artery and vein(s) deep to this. The vein is usually caudad relative to the artery.
  • The cords of the brachial plexus are seen as either hypoechoic or hyperechoic structures positioned around the axillary artery. The lateral cord is lateral (cephalad) to the artery, the medial cord medial (caudad),and the posterior cord posterior (deep). They can be difficult to visualize but are usually positioned closely to the artery.

Ultrasound settings

  • Probe: high-frequency (>10MHz) linear broadband probe.
  • Settings: MB-resolution/general.
  • Depth: 3-6cm.
  • Orientation: parasagittal.
  • Needle: 50-100mm depending on depth of plexus. Technique
  • An in-plane approach is recommended, inserted from the cephalad end of the transducer.
  • Needle tip visualization may be challenging as the needle angle can be quite steep.
  • Prepare the skin with 0.5% chlorhexidine in 70% alcohol. Wait until the skin is dry.
  • Anaesthetize the skin with a subcutaneous injection of 1% lidocaine at the point of needle insertion.
  • The needle is first advanced posterolateral to the artery to deposit local anesthetic around the posterior cord, 5 o'clock position on artery.
  • After careful aspiration LA is injected in small aliquots, observing the spread of the LA which ideally occurs behind and up both sides of the artery forming a 'U' shape around the artery, 1-9 o'clock around the artery.
  • If medial (caudad) spread is not observed then reinsertion of the needle between the axillary artery and vein, adjacent to the medial cord may be required.

研究设计

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

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 20-65 years old.
  • American society of anesthesiologist physical status (ASA): I-II.
  • Operation: forearm & hand surgeries.

排除标准

  • Patients with chronic pain
  • Those using chronic analgesic medications
  • History of brachial plexus injury
  • Allergy to the study drugs
  • Hepatic or renal insufficiency or infection at the site of injection

研究组 & 干预措施

group Levo-bupivacaine

Other

Group A (20 patients): Anesthesia will be performed with 35 ml of 0.5% levo-bupivacaine plus 1ml normal saline under the guidance of ultrasound for infraclavicular brachial plexus block.

干预措施: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex) (Drug)

group levo-bupivacaine plus 50µg dexmedetomidine

Other

Group B (20 patients): Anesthesia will be performed with 35 ml of 0.5% levo-bupivacaine plus 50µg dexmedetomidine under the guidance of ultrasound for infraclavicular brachial plexus block.

干预措施: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex) (Drug)

group levo-bupivacaine plus 100µg dexmedetomidine

Other

Group C (20 patients): Anesthesia will be performed with 35 ml of 0.5% levo-bupivacaine plus 100µg dexmedetomidine under the guidance of ultrasound for infraclavicular brachial plexus block.

干预措施: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex) (Drug)

结局指标

主要结局

onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)

时间窗: 24 hours

the modified Bromage scale (Three-point scale): Grade 0: Normal motor function, Grade 1: Decreased motor strength with the ability to move the fingers only, Grade 2: Complete motor block with an inability to move the fingers.

Duration of sensory block in hours

时间窗: 24 hours

It's the time from sensory block onset to the time of restoration of sensation at the surgical site

Onset time of sensory block in minutes

时间窗: 45 minutes

After the injection of the solution, every patient was checked for the onset of sensory blockade using goose soaked with iced normal saline by the following scale (three-point scale): Grade 0= perceived as normal sensation, Grade 1 = loss of cold sensation (analgesia), Grade 2= loss of sensation of touch (anesthesia).

Duration of motor block in hours

时间窗: 24 hours

It's the time from motor block onset to the restoration of global mobility in the hand and the wrist.

次要结局

  • heart rate in beats / minute(24 hours)
  • Visual analog scale (VAS)(24 hours)
  • Postoperative first analgesic request time in hours(24 hours)
  • Mean blood pressure in mmHg(24 hours)
  • peripheral oxygen saturation(24 hours)

研究者

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

Zaher Zaki Zaher

director

Aswan University Hospital

研究点 (1)

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