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

Phase 2

Recruiting

• Conditions: Postoperative Pain
• Interventions: Procedure: caudal block; Procedure: TAP; Drug: Dexmedetomidine; Drug: Bupivacain

• Registration Number: NCT06183073
• Lead Sponsor: Sohag University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-02
• Status Verified: 2023-12
• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2023-12-26
• Last Update Submitted: 2023-12-26
• Study First Posted: 2023-12-27
• Last Update Posted: 2023-12-27
• Primary Completion: 2024-01-14
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caudal block with bupivacaine and dexmedetomidine	Bupivacain	Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg.
Caudal block with bupivacaine and dexmedetomidine	caudal block	Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg.
TAP block with bupivacaine	Bupivacain	TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg).
TAP block with bupivacaine	TAP	TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg).
Caudal block with bupivacaine and dexmedetomidine	Dexmedetomidine	Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg.

Primary Outcome Measures

Name	Time	Method
1st analgesic requirement	12 hours	Time for first analgesic request (paracetamol intravenously 15 mg/kg) (h)

Secondary Outcome Measures

Name	Time	Method
SpO2 -Hemodynamic assessment	12 hours
post operative pain score	12 hours	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.
diastolic Blood Pressure (BP)	12 hours	Hemodynamic assessment
Total paracetamol consumption	12 hours
Heart rate (HR)	12 hours	Hemodynamic assessment
systolic Blood Pressure (BP)	12 hours	Hemodynamic assessment

Trial Locations

Locations (1)

Fouad Ibrahim Soliman; 🇪🇬 Sohag, Egypt