Regional Midazolam in Quadratus Lumborum Block

Not Applicable

Recruiting

• Conditions: Postoperative Pain
• Interventions: Drug: Midazolam/ bupivaciane; Drug: Bupivacain

• Registration Number: NCT05261672
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-02
• Study Start: 2022-03-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group QL2	Midazolam/ bupivaciane	quadratus lumborum block will be done. ) 20 ml bupivacaine 0.25% will be injected + 2 mg midazolam in 1 ml saline on each side.
Group QL1	Bupivacain	quadratus lumborum block will be done. 20 ml bupivacaine 0.25% will be injected + 1 ml saline on each side

Primary Outcome Measures

Name	Time	Method
rescue analgesia	24 hours	Time to rescue analgesia in the post operative period

Secondary Outcome Measures

Name	Time	Method
Visual analog scale	2, 4, 6, 8, 12, 16, 20, 24 hours	Pain Visual analog scale during the 1st 24 hours

Trial Locations

Locations (1)

Emad Zarief Kamel Said; 🇪🇬 Assiut, Egypt