NCT05708989

Caudal vs. Pudendal Block in Peds GU

Caudal vs. Pudendal Block for Early Postoperative Pain Control in a Pediatric Population Undergoing Lower Genitourinary Surgery

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: Male
• Age: 6 Months – 3 Years
• Healthy volunteers: Not accepted

Summary

This study will compare two techniques to minimize pain during and after penile surgery in children undergoing certain urologic surgeries. These two approaches include the caudal nerve block and the pudendal nerve block.

Conditions

• Hypospadias
• Penile Torsion
• Chordee
• Phimosis

Interventions

Type	Name	Description
PROCEDURE	Caudal Block	Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine into caudal spinal space. First attempt will be landmark-guided into the caudal spine region. Subsequent attempt(s) may be done using ultrasound.
PROCEDURE	Ultrasound-guided Pudendal Block	Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine. Ultrasound-guided injection into each pudendal nerve region through skin of buttocks.
DRUG	Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine	Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine into caudal spinal space. First attempt will be landmark-guided into the caudal spine region. Subsequent attempt(s) may be done using ultrasound.
DRUG	Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine.	Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine. Ultrasound-guided injection into each pudendal nerve region through skin of buttocks.

Timeline

• Start date: 2023-03-06
• Primary completion: 2025-02-01
• Completion: 2025-05-01
• First posted: 2023-02-01
• Last updated: 2024-07-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study