Regional Midazolam in Quadratus Lumborum Block

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Midazolam/ bupivaciane
* Drug: Bupivacain


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group QL1<br>quadratus lumborum block will be done. 20 ml bupivacaine 0.25% will be injected + 1 ml saline on each side | Drug: Bupivacain<br>* 20 ml bupivacaine 0.25% will be injected + 1 ml saline on each side<br>|
| Active Comparator: Group QL2<br>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<br>* 20 ml bupivacaine 0.25% will be injected + 2 mg midazolam in 1 ml saline on each side.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rescue analgesia | Time to rescue analgesia in the post operative period | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale | Pain Visual analog scale during the 1st 24 hours | 2, 4, 6, 8, 12, 16, 20, 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Midazolam, Bupivacaine