Clinical Trial: Effect of Caudal and Penile Block on Hypospadias Repair Complications

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Caudal and Penile Block on Hypospadias Repair Complications

Brief Summary: Hypospadias is one of the most common genitourinary (GU) malformations, seen in approximately 1 of 250 male live births. Common methods of local anesthesia administration for hypospadias surgery include caudal and dorsal penile nerve blocks. While both methods are known to be effective with minimal risk, the effect on post-operative complications is not well-established. The purpose of this randomized controlled trial is to evaluate if caudal versus dorsal penile nerve block results in higher rates of post-operative complications.

Detailed Summary:

Hypospadias is a one of the most common genitourinary (GU) malformations, seen in approximately 1 of 250 male live births, characterized by proximal location of the urethral meatus, dorsal hooded foreskin with incomplete ventral fusion, and ventral curvature of the penis. Hypospadias repair includes several standard steps including urethroplasty, mobilization of adjacent flaps for urethroplasty coverage, rotation of penile skin flaps and circumcision. In order for the surgeon to operate in a clean and relatively bloodless field, tourniquets and local epinephrine injection have been used. In a rabbit hypospadias repair model, the authors used both tourniquet and local epinephrine infiltration to maintain a clear surgical field, and showed increased apoptotic urethral myocytes on TUNNEL assay and collagen deposition in the epinephrine cohort. The study also showed structural changes in the mitochondria on scanning electron microscopy in the epinephrine cohort. This is the only hypospadias study demonstrating pathologic changes in the urethra after tourniquet or epinephrine injection. While single stage hypospadias surgical techniques have standardized significantly over the two decades, surgical complications can still occur in up to 28% of patients. Complications include urethrocutaneous fistulas, meatal stenosis, glans dehiscence, urethral strictures, and urethral diverticulum. Risk factors for hypospadias surgical complications have been extensively published and include: proximal urethral location, previous operation, glans width <14 mm, no urethroplasty coverage layers, surgeon learning curve, and age <4 years old.

The majority of hypospadias surgical complications need to be revised surgically and this results in significant financial and emotional burden for the family. The financial impact of hypospadias visits, repairs, and reoperations on society is largely
Sponsor: Baylor College of Medicine

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Baylor College of Medicine

Dates:
Date Received: July 28, 2016
Date Started: July 2016
Date Completion: August 2021
Last Updated: August 1, 2016
Last Verified: August 2016