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| Name | Class |
|---|---|
| Stanford University | OTHER |
| Dartmouth-Hitchcock Medical Center | OTHER |
| Boston Children's Hospital | OTHER |
| Children's Medical Center of Dallas/UT Southwestern |
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This is a prospective randomized multi-center non-inferiority trial conducted through the Pediatric Regional Anesthesia Network study sites to determine if caudal block increases the incidence of urethrocutaneous fistula following distal or mid shaft hypospadias repair compared with penile nerve block.
Small retrospective series are in conflict about whether there is an association between caudal block and urethrocutaneous fistulas after hypospadias repair. The most common alternative to caudal blockade is a penile nerve block. The investigators will test the following hypothesis:
There is no difference in the incidence of urethrocutaneous fistula formation following single stage hypospadias repair with caudal anesthesia compared with penile nerve block.
The investigators will use a prospective randomized controlled design where subjects will receive either a caudal block or a penile nerve block to provide postoperative analgesia. Meatal anatomy will be graded by the urologist in the anesthetized child according to the HOPE (Hypospadias Objective Penile Evaluation) score, a validated scoring system. Both the total score and the individual component scores will be recorded. The operating urologist will determine the presence or absence of a fistula at the postoperative visit about 12 weeks after surgery, with subsequent follow up at 6 months and again at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caudal block | Active Comparator | Patients will receive a caudal block with 0.75-1ml/kg of 0.2% ropivacaine. |
|
| Penile Nerve Block | Active Comparator | Patients will receive a dorsal penile nerve block with up to 0.75ml/kg of 0.25% bupivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caudal block with ropivacaine | Drug | Patients in this arm will receive a caudal block with ropivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of urethrocutaneous fistula | Presence of a urethrocutaneous fistula at postoperative visit up to 1 year after surgery. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of efficacy of caudal block | Blocks will be graded for efficacy using the following scale: Successful, Probably Successful, Probably Failed, or Failed. | 1 hour after arrival in Post Anesthesia Care Unit (PACU) post surgery |
| Degree of pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan Brockel, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
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| UNKNOWN |
| University of Mississippi Medical Center | OTHER |
| University of New Mexico | OTHER |
| University of Michigan | OTHER |
| Children's National Research Institute | OTHER |
| University of Wisconsin, Madison | OTHER |
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| penile nerve block with bupivacaine | Drug | Patients in this arm will receive a penile block with bupivacaine |
|
Patients will have pain scores determined using the modified FLACC score (Face, Legs, Activity, Cry, Consolability) 1 hour after arrival in the PACU
| 1 hour after arrival in PACU post surgery |
| Need for supplemental analgesics | Administration of opioid in the first postoperative hour will be determined | 1 hour after arrival in PACU post surgery |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 18, 2025 | Oct 7, 2025 | 11 |
| ID | Term |
|---|---|
| D007021 | Hypospadias |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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