Effect of Caudal and Penile Block on Hypospadias Repair Complications
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ClinicalTrials.gov Identifier: NCT02851290 |
Recruitment Status :
Active, not recruiting
First Posted : August 1, 2016
Last Update Posted : March 2, 2022
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Condition or disease | Intervention/treatment | Phase |
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Hypospadias | Procedure: Caudal block anesthesia Procedure: Dorsal penile nerve block anesthesia | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 66 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effect of Caudal and Penile Block on Hypospadias Repair Complications |
Study Start Date : | July 2016 |
Estimated Primary Completion Date : | July 2023 |
Estimated Study Completion Date : | August 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Caudal block
Local anesthetic will be administered into the caudal space
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Procedure: Caudal block anesthesia
After induction of general anesthesia, a caudal block will be performed using 0.75-1 mL/kg of 0.2% ropivacaine without epinephrine |
Active Comparator: Dorsal penile nerve block
Local anesthetic will be administered around the dorsal penile nerve
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Procedure: Dorsal penile nerve block anesthesia
After induction of general anesthesia, a dorsal penile nerve block will be performed using 0.75-1 mL/kg of 0.2% ropivacaine without epinephrine |
- Post-operative hypospadias repair complications [ Time Frame: 24 months post-operatively ]Post-operative follow-up to evaluate for post-operative complications including urethrocutaneous fistula, glans dehiscence, meatal stenosis, and urethral stricture
- Post-operative hypospadias repair pain [ Time Frame: 1 hour post-operatively ]Post-operative pain will be assessed using the FLACC scale (faces, legs, activity, cry and consolability scale)
- Caudal block-related complications [ Time Frame: 1 hour post-operatively ]Complications related to caudal block
- Dorsal penile nerve block-related complications [ Time Frame: 1 hour post-operatively ]Complications related to dorsal penile nerve block

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Ages Eligible for Study: | 4 Months to 4 Years (Child) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Age 4 months to 4 years
- ASA score I and II
- Primary hypospadias repair in one stage including distal, midshaft, and proximal repairs
Exclusion criteria:
- Age <4 months or >4 years
- ASA score >II
- Genetic syndromes
- Previous hypospadias operations
- Staged hypospadias repair operations
- Spinal dysraphism or other contraindications to caudal block
- Infection at the block site
- Refusal of consent by the parents
- Unwillingness of the anesthesiologist or surgeon to participate

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02851290
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Nicolette K Janzen, MD | Texas Children's Hospital/Baylor College of Medicine | |
Study Director: | Kara Toman, MPH | Texas Children's Hospital/Baylor College of Medicine |
Responsible Party: | Nicolette Janzen, Assistant Professor Pediatric Urology, Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT02851290 |
Other Study ID Numbers: |
H-38540 |
First Posted: | August 1, 2016 Key Record Dates |
Last Update Posted: | March 2, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Hypospadias Caudal block Dorsal penile nerve block Anesthesia |
Urethrocutaneous fistula Urethral stricture Meatal stenosis Glanular dehiscence |
Hypospadias Penile Diseases Urogenital Abnormalities Congenital Abnormalities |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |