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Ultrasound Guided Quadratus Lumborum Block Compared to Caudal Bupivacaine/ Neostigmine in Pediatric Lower Abdominal Surgeries

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT04720287
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
2.9
Actual Duration (Months)
20.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to compare the postoperative pain control in children undergoing lower abdominal surgeries receiving QL block with those receiving caudal bupivacaine/ neostigmine.

Condition or Disease Intervention/Treatment Phase
  • Drug: bupivacaine/ neostigmine.
  • Drug: bupivacaine/ neostigmine.
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Ultrasound Guided Quadratus Lumborum Block Compared to Caudal Bupivacaine/ Neostigmine in Pediatric Lower Abdominal Surgeries, a Randomized Controlled Trial
Actual Study Start Date :
Feb 1, 2021
Actual Primary Completion Date :
Apr 30, 2021
Actual Study Completion Date :
Apr 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group 1(QL group)

Drug: bupivacaine/ neostigmine.
will receive bilateral ultrasound guided QLB
Active Comparator: Group 2 (CB group)

Drug: bupivacaine/ neostigmine.
will receive ultrasound guided CB.

Outcome Measures

Primary Outcome Measures

  1. The total amount of paracetamol doses (mg) [24 hours postoperatively]

    The total amount of paracetamol doses (mg)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patients American Society of Anesthesiologists physical status (ASA) I or II.

  • Consent from parents or legal guardian(s).

  • Lower abdominal surgeries.

Exclusion Criteria:

  • Parents' refusal or legal guardian's refusal.

  • Infection at the injection site.

  • Known allergy to bupivacaine and/or neostigmine.

  • Contraindications to regional anesthesia (including coagulopathy and local infection).

  • Anatomical anomalies at the site of the block.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain-Shams University Hospitals Cairo Egypt

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr.Ibrahim Mamdouh Esmat, Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt., Ain Shams University
ClinicalTrials.gov Identifier:
NCT04720287
Other Study ID Numbers:
  • FMASU MS 728/2020/2021
First Posted:
Jan 22, 2021
Last Update Posted:
May 27, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Bupivacaine
Neostigmine

Study Results

No Results Posted as of May 27, 2021