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

Ultrasound Guided Quadratus Lumborum Block Compared to Caudal Bupivacaine/ Neostigmine in Pediatric Lower Abdominal Surgeries, a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Analgesia
• Intervention / Treatment: Drug: bupivacaine/ neostigmine.; Drug: bupivacaine/ neostigmine.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain-Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1(QL group)	Drug: bupivacaine/ neostigmine.; will receive bilateral ultrasound guided QLB; Drug: bupivacaine/ neostigmine.; will receive ultrasound guided CB.
Active Comparator: Group 2 (CB group)	Drug: bupivacaine/ neostigmine.; will receive bilateral ultrasound guided QLB; Drug: bupivacaine/ neostigmine.; will receive ultrasound guided CB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total amount of paracetamol doses (mg)	The total amount of paracetamol doses (mg)	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anesthetics, Local; Cholinesterase Inhibitors; Parasympathomimetics; Bupivacaine; Neostigmine
• Other Study ID Numbers: FMASU MS 728/2020/2021

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