Back to resultsQuadratus Lumborum vs Caudal Epidural Block for Perioperative Analgesia in Pediatric Patients for Upper Abdominal Surgeries
Primary Purpose
Post Operative Pain, Acute
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Quadratus lumborum block
Caudal epidural injection
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain, Acute
Eligibility Criteria
Inclusion Criteria:
- Any pediatric patient aged from 2 to 8 years undergoing abdominal Surgery with Supraumbilical umbilical incision
Exclusion Criteria:
- parents refusal to participate in the study,
- previous history of allergy to local anesthetics
- hemodynamic instability
- Coagulopathy,
Sites / Locations
- Ain shams university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Quadratus Lumborum
Caudal epidural
Arm Description
Patients will receive Ultrasound-guided quadratus lumborum block
Patients will receive single Caudal epidural injection
Outcomes
Primary Outcome Measures
Pain score
Face, leg, activity, cry and consolability score With score of 0 meaning no pain and requires no intervention and score of 10 indicating the worst imaginable pain requiring rescue analgesia
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05493085
Brief Title
Quadratus Lumborum vs Caudal Epidural Block for Perioperative Analgesia in Pediatric Patients for Upper Abdominal Surgeries
Official Title
Quadratus Lumborum vs Caudal Epidural Block for Perioperative Analgesia in Pediatric Patients Undergoing Upper Abdominal Surgeries.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Compare between the analgesic effect of the Ultrasound-guided quadratus lumborum block and single Caudal epidural injection in pediatric patients undergoing surgeries with supraumbilical incisions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Quadratus Lumborum
Arm Type
Active Comparator
Arm Description
Patients will receive Ultrasound-guided quadratus lumborum block
Arm Title
Caudal epidural
Arm Type
Active Comparator
Arm Description
Patients will receive single Caudal epidural injection
Intervention Type
Procedure
Intervention Name(s)
Quadratus lumborum block
Intervention Description
Ultrasound-guided quadratus lumborum block
Intervention Type
Procedure
Intervention Name(s)
Caudal epidural injection
Intervention Description
Single Caudal epidural injection
Primary Outcome Measure Information:
Title
Pain score
Description
Face, leg, activity, cry and consolability score With score of 0 meaning no pain and requires no intervention and score of 10 indicating the worst imaginable pain requiring rescue analgesia
Time Frame
24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Any pediatric patient aged from 2 to 8 years undergoing abdominal Surgery with Supraumbilical umbilical incision
Exclusion Criteria:
parents refusal to participate in the study,
previous history of allergy to local anesthetics
hemodynamic instability
Coagulopathy,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed A Tolba, MD
Phone
0020 115 6622298
Email
Mohamedtolba@med.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Aya H Moussa, MD
Phone
0020 1114555939
Email
ayahisham@med.asu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif Wadei, MD
Organizational Affiliation
AinShams University, Anesthesia department
Official's Role
Study Chair
Facility Information:
Facility Name
Ain shams university hospital
City
Cairo
State/Province
Abbasia
ZIP/Postal Code
11213
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed A Tolba, MD
Phone
01156622298
Ext
002
Email
Mohamedtolba@med.asu.edu.eg
First Name & Middle Initial & Last Name & Degree
Aya H Moussa, MD
Phone
01114555939
Ext
002
Email
Ayahisham@med.asu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Quadratus Lumborum vs Caudal Epidural Block for Perioperative Analgesia in Pediatric Patients for Upper Abdominal Surgeries
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