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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06183073

Enrollment

Registered

2023-12-27

Start date

2023-04-02

Completion date

2024-02-01

Last updated

2023-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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).

Interventions

PROCEDUREcaudal block

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

DRUGDexmedetomidine

dexmedetomidine 1μg/ kg.

PROCEDURETAP

analgesia

DRUGBupivacain

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 9 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Heart rate (HR)	12 hours	Hemodynamic assessment
systolic Blood Pressure (BP)	12 hours	Hemodynamic assessment
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.
SpO2 -Hemodynamic assessment	12 hours	—
Total paracetamol consumption	12 hours	—
diastolic Blood Pressure (BP)	12 hours	Hemodynamic assessment

Countries

Egypt

Contacts

Primary ContactFouad I Soliman, MD

fouad_soliman@med.sohag.edu.eg01113815186

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026