Caudal Block With Bupivacaine and Dexmedetomidine Versus TAP Block With Bupivacaine Alone for Postoperative Analgesia in Pediatric Undergoing Infraumbical Surgeries

Analgesic Efficacy of Transversus Abdominis Plane Block Versus Caudal Dexmedetomidine in Children Undergoing Abdominal Surgeries

Acute pain management for pediatric surgical patients intraoperatively and postoperatively is important for their comfort and psychological impact. Children aged 3-9 years old are included in the study and are divided randomly into two groups (45 children in each):

Group D: Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg.

Group T: TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg).

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: caudal block; Drug: Dexmedetomidine; Drug: Bupivacain; Procedure: TAP

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fouad I Soliman, MD; Phone Number: 01113815186; Email: fouad_soliman@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt, 52514
    • Recruiting
    • Fouad Ibrahim Soliman
    • Contact: Fouad I Soliman, MD; Phone Number: 01113815186; Email: fouad_soliman@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Children aged 3-9 years old
• Physical status I and II class of the American Society of Anesthesiologists (ASA)
• Unilateral elective surgeries below the umbilicus

Exclusion Criteria:

• Parents or legal guardian refusal.
• History of developmental delay or mental retardation
• Contraindications to regional anesthesia as known or suspected coagulopathy, a known allergy to any of the study drugs, signs of infection at the site of caudal block.
• Hemodynamic unstable patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Caudal block with bupivacaine and dexmedetomidine; Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg.	Procedure: caudal block; bupivacaine 0.25% in a dose of (1 ml / kg); Other Names: bupivacaine; Drug: Dexmedetomidine; dexmedetomidine 1μg/ kg.; Drug: Bupivacain; bupivacaine 0.25% in a dose of (0.5 ml / kg
Active Comparator: TAP block with bupivacaine; TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg).	Drug: Bupivacain; bupivacaine 0.25% in a dose of (0.5 ml / kg; Procedure: TAP; analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1st analgesic requirement	Time for first analgesic request (paracetamol intravenously 15 mg/kg) (h)	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate (HR)	Hemodynamic assessment	12 hours
systolic Blood Pressure (BP)	Hemodynamic assessment	12 hours
diastolic Blood Pressure (BP)	Hemodynamic assessment	12 hours
SpO2 -Hemodynamic assessment		12 hours
Total paracetamol consumption		12 hours
post operative pain score	post operative pain score upon arrival to recovery room and then 2, 4,6, 8 , and 12 hours after surgery using Faces pain scale-revised.	12 hours

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Fouad I Soliman, MD, Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2023
• Primary Completion (Estimated): January 14, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 26, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: 2009 (Organization for Autism Research)

Drug and device information, study documents

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