Caudal vs. Pudendal Block in Peds GU

University Hospitals (UH)

Status and phase: Withdrawn; Phase 4

Conditions: Penile Torsion; Phimosis; Hypospadias; Chordee

Treatments: Procedure: Caudal Block; Drug: Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine.; Procedure: Ultrasound-guided Pudendal Block; Drug: Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05708989

STUDY20220033

Details and patient eligibility

About

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.

Sex: Male

Ages: 6 months to 3 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergoing penile genitourinary surgery
• ASA class 1-3

Exclusion criteria

• Female patients
• Male children <6 months or >/= 3 years of age
• ASA class >3
• Surgery at satellite location (non-Prentiss)
• Concurrent non-lower GU tract surgery
• Sacrospinal abnormality
• History of chronic pain requiring opioid analgesics
• Inability to tolerate and receive acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), alpha-2 agonists, or local anesthetics
• History of malignant hyperthermia
• History of coagulopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Caudal Block

Active Comparator group

Description:

Patients will receive a caudal block prior to surgery.

Treatment:

Drug: Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine

Procedure: Caudal Block

Pudendal Block

Experimental group

Description:

Patients will receive a pudendal block prior to surgery.

Treatment:

Drug: Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine.

Procedure: Ultrasound-guided Pudendal Block