Regional Midazolam in Quadratus Lumborum Block

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05261672
• Other study ID #: IRB022022
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: January 20, 2024

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: Emad Z Kamel, MD
• Phone: +201007046058
• Email: emadzarief[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 20, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 24 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Midazolam/ bupivaciane
20 ml bupivacaine 0.25% will be injected + 2 mg midazolam in 1 ml saline on each side.
• Bupivacain
20 ml bupivacaine 0.25% will be injected + 1 ml saline on each side

Locations

Country	Name	City	State
Egypt	Emad Zarief Kamel Said	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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 Ju — View 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-i — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	total Analgesic requirement	total Analgesic requirement in the first 24 hours	first 24 hours
Primary	rescue analgesia	Time to rescue analgesia in the post operative period	24 hours
Secondary	Visual analog scale	Pain Visual analog scale during the 1st 24 hours	2, 4, 6, 8, 12, 16, 20, 24 hours