Caudal vs. Pudendal Block in Peds GU

Sponsor

University Hospitals Cleveland Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05708989

Collaborator

(none)

138

Enrollment

Location

Arms

26.9

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypospadias Penile Torsion Chordee Phimosis	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.	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Caudal Block Patients will receive a caudal block prior to surgery.	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. 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.
Experimental: Pudendal Block Patients will receive a pudendal block prior to surgery.	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: 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.

Arm

Intervention/Treatment

Active Comparator: Caudal Block

Patients will receive a caudal block prior to surgery.

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.

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

Experimental: Pudendal Block

Patients will receive a pudendal block prior to surgery.

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: 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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 3 Years

Sexes Eligible for Study:

Male

Accepts 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