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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06183073
• Other study ID #: 2009
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: December 2023
• Source: Sohag University
• Contact: Fouad I Soliman, MD
• Phone: 01113815186
• Email: fouad_soliman[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 1, 2024
• Est. primary completion date: January 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• caudal block
bupivacaine 0.25% in a dose of (1 ml / kg)

Drug:
• Dexmedetomidine
dexmedetomidine 1µg/ kg.

Procedure:
• TAP
analgesia

Drug:
• Bupivacain
bupivacaine 0.25% in a dose of (0.5 ml / kg

Locations

Country	Name	City	State
Egypt	Fouad Ibrahim Soliman	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1st analgesic requirement	Time for first analgesic request (paracetamol intravenously 15 mg/kg) (h)	12 hours
Secondary	Heart rate (HR)	Hemodynamic assessment	12 hours
Secondary	systolic Blood Pressure (BP)	Hemodynamic assessment	12 hours
Secondary	diastolic Blood Pressure (BP)	Hemodynamic assessment	12 hours
Secondary	SpO2 -Hemodynamic assessment		12 hours
Secondary	Total paracetamol consumption		12 hours
Secondary	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