Hypospadias, Urethrocutaneous Fistula
Conditions
Keywords
hypospadias, caudal, urethrocutaneous fistula, penile nerve block
Brief summary
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.
Detailed description
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.
Interventions
DRUGCaudal block with ropivacaine
Patients in this arm will receive a caudal block with ropivacaine
DRUGpenile nerve block with bupivacaine
Patients in this arm will receive a penile block with bupivacaine
Sponsors
Stanford University
Dartmouth-Hitchcock Medical Center
Boston Children's Hospital
Children's Medical Center of Dallas/UT Southwestern
University of Mississippi Medical Center
University of New Mexico
University of Michigan
Children's National Research Institute
University of Wisconsin, Madison
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
4 Months to 2 Years
Healthy volunteers
No
Inclusion criteria
* infants/ children with midshaft or distal hypospadias undergoing primary single stage repair in one of the Pediatric Regional Anesthesia Network participating centers.
Exclusion criteria
* prior hypospadias surgery, * proximal or penoscrotal hypospadias, * abnormal caudal anatomy or spinal dysraphism, * cyanotic congenital heart disease, * infection or rash at the block injection site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of urethrocutaneous fistula | 1 year | Presence of a urethrocutaneous fistula at postoperative visit up to 1 year after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of efficacy of caudal block | 1 hour after arrival in Post Anesthesia Care Unit (PACU) post surgery | Blocks will be graded for efficacy using the following scale: Successful, Probably Successful, Probably Failed, or Failed. |
| Degree of pain | 1 hour after arrival in PACU post surgery | Patients will have pain scores determined using the modified FLACC score (Face, Legs, Activity, Cry, Consolability) 1 hour after arrival in the PACU |
| Need for supplemental analgesics | 1 hour after arrival in PACU post surgery | Administration of opioid in the first postoperative hour will be determined |
Countries
United States
Outcome results
None listed