Clinical trial NCT05261672: Regional Midazolam in Quadratus Lumborum Block
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Keywords: Midazolam
Bupivacaine
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: rescue analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: Visual analog scale
timeFrame: 2, 4, 6, 8, 12, 16, 20, 24 hours
Other outcomes:
measure: total Analgesic requirement
timeFrame: first 24 hours
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
citation: Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
citation: Ishio J, Komasawa N, Kido H, Minami T. Evaluation of ultrasound-guided posterior quadratus lumborum block for postoperative analgesia after laparoscopic gynecologic surgery. J Clin Anesth. 2017 Sep;41:1-4. doi: 10.1016/j.jclinane.2017.05.015. Epub 2017 Jun 1.
citation: Tucker AP, Mezzatesta J, Nadeson R, Goodchild CS. Intrathecal midazolam II: combination with intrathecal fentanyl for labor pain. Anesth Analg. 2004 Jun;98(6):1521-1527. doi: 10.1213/01.ANE.0000112434.68702.E4.
citation: Lefevre N, Klouche S, de Pamphilis O, Herman S, Gerometta A, Bohu Y. Peri-articular local infiltration analgesia versus femoral nerve block for postoperative pain control following anterior cruciate ligament reconstruction: Prospective, comparative, non-inferiority study. Orthop Traumatol Surg Res. 2016 Nov;102(7):873-877. doi: 10.1016/j.otsr.2016.07.011. Epub 2016 Oct 4.