Regional Midazolam in Quadratus Lumborum Block

Sponsor

Assiut University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05261672

Collaborator

(none)

Enrollment

Location

Arms

10.2

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Midazolam/ bupivaciane Drug: Bupivacain	N/A

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

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jan 20, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Group QL1

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

Drug: Bupivacain

20 ml bupivacaine 0.25% will be injected + 1 ml saline on each side

Active Comparator: Group QL2

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

Drug: Midazolam/ bupivaciane

20 ml bupivacaine 0.25% will be injected + 2 mg midazolam in 1 ml saline on each side.

Outcome Measures

Primary Outcome Measures

rescue analgesia [24 hours]
Time to rescue analgesia in the post operative period

Secondary Outcome Measures

Visual analog scale [2, 4, 6, 8, 12, 16, 20, 24 hours]
Pain Visual analog scale during the 1st 24 hours

Other Outcome Measures

total Analgesic requirement [first 24 hours]
total Analgesic requirement in the first 24 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emad Zarief Kamel Said	Assiut		Egypt	71111

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Emad Zarief , MD, prof., Assiut University

ClinicalTrials.gov Identifier:

NCT05261672

Other Study ID Numbers:

IRB022022

First Posted:

Mar 2, 2022

Last Update Posted:

Jul 5, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Emad Zarief , MD, prof., Assiut University

Midazolam

Bupivacaine

Additional relevant MeSH terms:

Pain, Postoperative

Midazolam

Bupivacaine

Study Results

No Results Posted as of Jul 5, 2022