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Regional Midazolam in Quadratus Lumborum Block

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Midazolam/ bupivaciane
Bupivacain
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Midazolam, Bupivacaine

Eligibility Criteria

24 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Emad Zarief Kamel SaidRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group QL1

Group QL2

Arm Description

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

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

Outcomes

Primary Outcome Measures

rescue analgesia
Time to rescue analgesia in the post operative period

Secondary Outcome Measures

Visual analog scale
Pain Visual analog scale during the 1st 24 hours

Full Information

First Posted
February 21, 2022
Last Updated
June 30, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05261672
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
January 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Midazolam, Bupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group QL1
Arm Type
Active Comparator
Arm Description
quadratus lumborum block will be done. 20 ml bupivacaine 0.25% will be injected + 1 ml saline on each side
Arm Title
Group QL2
Arm Type
Active Comparator
Arm Description
quadratus lumborum block will be done. ) 20 ml bupivacaine 0.25% will be injected + 2 mg midazolam in 1 ml saline on each side.
Intervention Type
Drug
Intervention Name(s)
Midazolam/ bupivaciane
Intervention Description
20 ml bupivacaine 0.25% will be injected + 2 mg midazolam in 1 ml saline on each side.
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Intervention Description
20 ml bupivacaine 0.25% will be injected + 1 ml saline on each side
Primary Outcome Measure Information:
Title
rescue analgesia
Description
Time to rescue analgesia in the post operative period
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Visual analog scale
Description
Pain Visual analog scale during the 1st 24 hours
Time Frame
2, 4, 6, 8, 12, 16, 20, 24 hours
Other Pre-specified Outcome Measures:
Title
total Analgesic requirement
Description
total Analgesic requirement in the first 24 hours
Time Frame
first 24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnancy with a gestation of at least 37 weeks
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emad Z Kamel, MD
Phone
+201007046058
Email
emadzarief@aun.edu.eg
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emad Z Kamel, M.D.
Phone
+201007046058
Email
emadzarief@aun.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26225500
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.
Results Reference
result
PubMed Identifier
28802593
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.
Results Reference
result
PubMed Identifier
15155300
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.
Results Reference
result
PubMed Identifier
27720193
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.
Results Reference
result

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Regional Midazolam in Quadratus Lumborum Block

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