NCT05261672

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2024

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

February 21, 2022

Last Update Submit

November 16, 2023

Conditions

Postoperative Pain

Keywords

MidazolamBupivacaine

Outcome Measures

Primary Outcomes (1)

  • rescue analgesia

    Time to rescue analgesia in the post operative period

    24 hours

Secondary Outcomes (1)

  • Visual analog scale

    2, 4, 6, 8, 12, 16, 20, 24 hours

Other Outcomes (1)

  • total Analgesic requirement

    first 24 hours

Study Arms (2)

Group QL1

ACTIVE COMPARATOR

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

Drug: Bupivacain

Group QL2

ACTIVE COMPARATOR

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

Interventions

Midazolam/ bupivacianeDRUG

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

Group QL2
BupivacainDRUG

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

Group QL1

Eligibility Criteria

Age24 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy with a gestation of at least 37 weeks
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

RECRUITING

Related 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.

    PMID: 26225500RESULT

  • 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.

    PMID: 28802593RESULT

  • 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.

    PMID: 15155300RESULT

  • 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.

    PMID: 27720193RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

MidazolamBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Emad Z Kamel, MD

CONTACT

+201007046058emadzarief@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof.

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 2, 2022

Study Start

March 15, 2022

Primary Completion

December 31, 2023

Study Completion

January 20, 2024

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)