Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants?

Hypospadias Clinical Trial

Official title:

Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? A Multi-center Prospective Randomized Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02861950
• Other study ID #: 15-2343
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 24, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 490
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 4 Months to 2 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fistula
• Hypospadias
• Urethrocutaneous Fistula

Intervention

Drug:
• Caudal block with ropivacaine
Patients in this arm will receive a caudal block with ropivacaine
• penile nerve block with bupivacaine
Patients in this arm will receive a penile block with bupivacaine

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (15)

Lead Sponsor

Collaborator

University of Colorado, Denver

Boston Children's Hospital, Children's Medical Center Dallas, Children's National Health System, Dartmouth-Hitchcock Medical Center, Joe DiMaggio Children's Hospital, Northwestern University, Oregon Health and Science University, Stanford University, The University of Texas Health Science Center, Houston, University of Iowa, University of Michigan, University of Mississippi Medical Center, University of New Mexico, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of urethrocutaneous fistula	Presence of a urethrocutaneous fistula at postoperative visit up to 1 year after surgery.	1 year
Secondary	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
Secondary	Degree of pain	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
Secondary	Need for supplemental analgesics	Administration of opioid in the first postoperative hour will be determined	1 hour after arrival in PACU post surgery