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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02861950
Other study ID # 15-2343
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Not yet recruiting NCT03698721 - Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate
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Terminated NCT04826484 - Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel Phase 3
Completed NCT02103712 - Long Term Outcome of Hypospadias Repair
Suspended NCT05093166 - Clinical Trial to Assess the Safety and Efficacy of Investigational Product in Patients Due to Hypospadias Treatment Failure Phase 1/Phase 2
Withdrawn NCT01762007 - The Change of the Detrusor Thickness After Hypospadias Repair - Comparison With the Normal Control Group
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Completed NCT02495090 - Hypospadias and Exome: Identification of New Genes for Familial Hypospadias N/A
Completed NCT04668183 - Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery
Completed NCT01370798 - Local Oestrogen Versus Placebo as Preoperative Treatment in Patients With Severe Hypospadias: Effects on Post-operative Complications Phase 3
Recruiting NCT06417060 - Caudal Anesthesia Versus Local Anesthesia in Hypospadias N/A
Not yet recruiting NCT06410482 - Analgesia in Pediatric Hypospadias Surgeries N/A
Terminated NCT02162810 - Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair N/A
Recruiting NCT05837000 - Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair Phase 4
Recruiting NCT05319782 - Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences N/A
Recruiting NCT05032222 - The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair
Completed NCT05144659 - Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics N/A
Suspended NCT05708989 - Caudal vs. Pudendal Block in Peds GU Phase 4