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

NCT06183073 | Unknown Phase 2 DMC

• 1 other identifier: 2009
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 1st analgesic requirement

  Time for first analgesic request (paracetamol intravenously 15 mg/kg) (h)

  12 hours

Secondary Outcomes (6)

• Heart rate (HR)

  12 hours

• systolic Blood Pressure (BP)

  12 hours

• diastolic Blood Pressure (BP)

  12 hours

• SpO2 -Hemodynamic assessment

  12 hours

• Total paracetamol consumption

  12 hours

Study Arms (2)

Caudal block with bupivacaine and dexmedetomidine

ACTIVE COMPARATOR

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

Procedure: caudal block; Drug: Dexmedetomidine; Drug: Bupivacain

TAP block with bupivacaine

ACTIVE COMPARATOR

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

Procedure: TAP; Drug: Bupivacain

Interventions

caudal block PROCEDURE

bupivacaine 0.25% in a dose of (1 ml / kg)

Also known as: bupivacaine

Caudal block with bupivacaine and dexmedetomidine

Dexmedetomidine DRUG

dexmedetomidine 1μg/ kg.

Caudal block with bupivacaine and dexmedetomidine

TAP PROCEDURE

analgesia

TAP block with bupivacaine

Bupivacain DRUG

bupivacaine 0.25% in a dose of (0.5 ml / kg

Caudal block with bupivacaine and dexmedetomidine; TAP block with bupivacaine

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Fouad Ibrahim Soliman

Sohag, 52514, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fouad I Soliman, MD

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fouad I Soliman, MD

CONTACT

01113815186; fouad_soliman@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and ICU

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: April 2, 2023
• Primary Completion: January 14, 2024
• Study Completion: February 1, 2024
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

EG (1)