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Regional Midazolam in Quadratus Lumborum Block

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05261672
Enrollment
60
Registered
2022-03-02
Start date
2022-03-15
Completion date
2024-01-20
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Midazolam, Bupivacaine

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.

Interventions

DRUGMidazolam/ bupivaciane

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

DRUGBupivacain

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
24 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
rescue analgesia24 hoursTime to rescue analgesia in the post operative period

Secondary

MeasureTime frameDescription
Visual analog scale2, 4, 6, 8, 12, 16, 20, 24 hoursPain Visual analog scale during the 1st 24 hours

Other

MeasureTime frameDescription
total Analgesic requirementfirst 24 hourstotal Analgesic requirement in the first 24 hours

Countries

Egypt

Contacts

Primary ContactEmad Z Kamel, MD
emadzarief@aun.edu.eg+201007046058

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026