Quadratus Lumborum vs Caudal Epidural Block for Perioperative Analgesia in Pediatric Patients for Upper Abdominal Surgeries

Quadratus Lumborum vs Caudal Epidural Block for Perioperative Analgesia in Pediatric Patients Undergoing Upper Abdominal Surgeries.

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.

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain, Acute
• Intervention / Treatment: Procedure: Quadratus lumborum block; Procedure: Caudal epidural injection

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed A Tolba, MD; Phone Number: 0020 115 6622298; Email: Mohamedtolba@med.asu.edu.eg
• Study Contact Backup: Name: Aya H Moussa, MD; Phone Number: 0020 1114555939; Email: ayahisham@med.asu.edu.eg

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 11213
      • Recruiting
      • Ain Shams University Hospital
      • Contact: Mohamed A Tolba, MD; Phone Number: 002 01156622298; Email: Mohamedtolba@med.asu.edu.eg
      • Contact: Aya H Moussa, MD; Phone Number: 002 01114555939; Email: Ayahisham@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Quadratus Lumborum; Patients will receive Ultrasound-guided quadratus lumborum block	Procedure: Quadratus lumborum block; Ultrasound-guided quadratus lumborum block
Active Comparator: Caudal epidural; Patients will receive single Caudal epidural injection	Procedure: Caudal epidural injection; Single Caudal epidural injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hours postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Sherif Wadei, MD, AinShams University, Anesthesia department

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: FMASU R 69/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No