Clinical trial

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

Name

STUDY20220033

Description

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.

Trial arms

Trial start

2023-03-06

Estimated PCD

2025-02-01

Trial end

2025-05-01

Phase

Early phase I

Treatment

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.

Arms:

Caudal Block

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.

Arms:

Pudendal Block

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

Arms:

Caudal Block

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.

Arms:

Pudendal Block

Size

138

Primary endpoint

Rescue Narcotic Administration

During post-operative in-hospital recovery, approximately 1 hour

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 138, 'type': 'ESTIMATED'}}

Updated at

2023-09-01

1 organization

2 products

4 indications

Organization

University Hospitals Cleveland Medical Center

Product

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

Indication

Indication

Indication

Indication

Product

Ropivacaine + Dexmetomedine