Caudal vs. Pudendal Block in Peds GU

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypospadias, Penile Torsion, Chordee, Phimosis

Intervention / Treatment
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* 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.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caudal Block<br>Patients will receive a caudal block prior to surgery. | Procedure: Caudal Block<br>* 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.<br>Drug: Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine<br>* 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.<br>|
| Experimental: Pudendal Block<br>Patients will receive a pudendal block prior to surgery. | Procedure: Ultrasound-guided Pudendal Block<br>* 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.<br>Drug: Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue Narcotic Administration | Dose (mg) of postoperative rescue opioid | During post-operative in-hospital recovery, approximately 1 hour | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caudal block, pudendal block, regional anesthesia