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临床试验/NCT05261672
NCT05261672招募中不适用

Midazolam as an Adjuvant to Bupivacaine in Quadratus Lumborum Block After Caesarean Section; Does it Offer Better Pain Control? a Randomized Double Blind Clinical Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月15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
60
试验地点
1
主要终点
rescue analgesia

研究概览

简要总结

Midazolam has been used in regional anesthesia of brachial plexus block; it has offered accepted postoperative pain relief. This study will use it in as an adjuvant to bupivacaine 0.25% in quadratus lumborum block in caesarean section

详细描述

It is vital to apply adequate postoperative analgesia following Caesarean section (C-section), since it will affect the distinct surgical recovery requirements of the parturient. The ultrasound-guided quadratus lumborum block (QLB), first introduced by Blanco R. in 2007, has been recognized as an effective abdominal wall block approach, in which local anesthetic injected from the posterior abdomen will spread around the quadratus lumborum muscle and block the intermuscular nerves. In addition, such block is also closely related to multiple sympathetic fibres and is connected to the thoracic paravertebral space. Typically, QLB is found to be effective, which can provide satisfactory analgesic effect.

Midazolam is one of the clinically water-soluble benzodiazepines and effective to produce the analgesic effect through the neuraxial pathways. The organs and joints of humans have the benzodiazepine receptor, and midazolam is revealed to produce the analgesic effect through the gamma-aminobutyric acid receptors (GABA) in the spinal cord. Previous studies have reported that the midazolam (75 μg/kg) through the intraarticular route can decrease the pain intensity for arthroscopic knee surgery. In addition, the intrathecal midazolam (2 mg) is reported to prolong the duration of analgesia without any adverse effects following knee arthroscopies. Perineural midazolam has been also evaluated in brachial plexus 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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
24 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) physical status I or II
  • age from 24 to 40 years old
  • weight from 50 to 80 kg,
  • normal singleton pregnancy with a gestation of at least 37 weeks

排除标准

  • Coagulopathy
  • maternal anatomic abnormalities in the block region
  • localized infection
  • incapable of comprehending or using the verbal rating pain scoring system
  • Included medications allergy
  • history of chronic pain or regular opioid use.

研究组 & 干预措施

Group QL1

Active Comparator

quadratus lumborum block will be done. 20 ml bupivacaine 0.25% will be injected + 1 ml saline on each side

干预措施: Bupivacain (Drug)

Group QL2

Active Comparator

quadratus lumborum block will be done. ) 20 ml bupivacaine 0.25% will be injected + 2 mg midazolam in 1 ml saline on each side.

干预措施: Midazolam/ bupivaciane (Drug)

结局指标

主要结局

rescue analgesia

时间窗: 24 hours

Time to rescue analgesia in the post operative period

次要结局

  • Visual analog scale(2, 4, 6, 8, 12, 16, 20, 24 hours)

研究者

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

Emad Zarief , MD

prof.

Assiut University

研究点 (1)

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