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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypospadias; Urethrocutaneous Fistula
• Intervention / Treatment: Drug: Caudal block with ropivacaine; Drug: penile nerve block with bupivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Caudal block; Patients will receive a caudal block with 0.75-1ml/kg of 0.2% ropivacaine.	Drug: Caudal block with ropivacaine; Patients in this arm will receive a caudal block with ropivacaine
Active Comparator: Penile Nerve Block; Patients will receive a dorsal penile nerve block with up to 0.75ml/kg of 0.25% bupivacaine.	Drug: penile nerve block with bupivacaine; Patients in this arm will receive a penile block with bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of urethrocutaneous fistula	Presence of a urethrocutaneous fistula at postoperative visit up to 1 year after surgery.	1 year

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: University of Michigan; Boston Children's Hospital; University of Wisconsin, Madison; Dartmouth-Hitchcock Medical Center; Stanford University; University of New Mexico; University of Mississippi Medical Center; Children's National Health System; Children's Medical Center of Dallas/UT Southwestern
• Investigators: Principal Investigator: Megan Brockel, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2017
• Primary Completion (Actual): September 20, 2023
• Study Completion (Actual): September 20, 2023

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimated): August 10, 2016

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: hypospadias; penile nerve block; urethrocutaneous fistula; caudal
• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Pathological Conditions, Anatomical; Penile Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Fistula; Hypospadias; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine
• Other Study ID Numbers: 15-2343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No