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
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
systolic Blood Pressure (BP)	12 hours	Hemodynamic assessment
SpO2 -Hemodynamic assessment	12 hours
Heart rate (HR)	12 hours	Hemodynamic assessment

Trial Locations

Locations (1)

Fouad Ibrahim Soliman; 🇪🇬 Sohag, Egypt