Caudal vs. Pudendal Block in Peds GU

Phase 4

Withdrawn

• Conditions: Penile Torsion; Phimosis; Hypospadias; Chordee
• Interventions: Procedure: Caudal Block; Procedure: Ultrasound-guided Pudendal Block; Drug: Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine; Drug: Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine.

• Registration Number: NCT05708989
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-01-23
• Study First Posted: 2023-02-01
• Study Start: 2023-03-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-02
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Undergoing penile genitourinary surgery
• ASA class 1-3

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caudal Block	Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine	Patients will receive a caudal block prior to surgery.
Caudal Block	Caudal Block	Patients will receive a caudal block prior to surgery.
Pudendal Block	Ultrasound-guided Pudendal Block	Patients will receive a pudendal block prior to surgery.
Pudendal Block	Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine.	Patients will receive a pudendal block prior to surgery.

Primary Outcome Measures

Name	Time	Method
Rescue Narcotic Administration	During post-operative in-hospital recovery, approximately 1 hour	Dose (mg) of postoperative rescue opioid

Secondary Outcome Measures

Name	Time	Method
Non-Narcotic Rescue Administration at 24 hours	During first day after surgery, approximately 24 hours	Dose (mg) of non-narcotic rescue medication
Non-Narcotic Rescue Administration at 48 hours	During second day after surgery, approximately 48 hours	Dose (mg) of non-narcotic rescue medication
Non-Narcotic Rescue Administration at 72 hours	During third day after surgery, approximately 72 hours	Dose (mg) of non-narcotic rescue medication
Number of participants with at least one adverse event (AE) as measured by patient report	End of study, up to 3 months	Adverse events will include any AE related to study procedure

Trial Locations

Locations (1)

UH Rainbow Babies and Children's Hospital; 🇺🇸 Cleveland, Ohio, United States