HypospadiasPhase 4NCT02861950
Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants?
A Phase 4 study testing Caudal block with ropivacaine and penile nerve block with bupivacaine in people with Hypospadias and Urethrocutaneous Fistula, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 months to 2 years, men only
- Conditions the study is for
- Hypospadias, Urethrocutaneous Fistula
- What is being tested?
- Caudal block with ropivacaine and penile nerve block with bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2017to 20 Sep 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 2 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- infants/ children with midshaft or distal hypospadias undergoing primary single stage repair in one of the Pediatric Regional Anesthesia Network participating centers.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypospadias, Urethrocutaneous Fistula
- Being tested
- Caudal block with ropivacaine, penile nerve block with bupivacaine
- Keywords
- hypospadias, caudal, urethrocutaneous fistula, penile nerve block
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal block with ropivacaineDrug
Patients in this arm will receive a caudal block with ropivacaine
penile nerve block with bupivacaineDrug
Patients in this arm will receive a penile block with bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Caudal block | Active comparator | Patients will receive a caudal block with 0.75-1ml/kg of 0.2% ropivacaine. Receives: Drug: Caudal block with ropivacaine |
| Penile Nerve Block | Active comparator | Patients will receive a dorsal penile nerve block with up to 0.75ml/kg of 0.25% bupivacaine. Receives: Drug: penile nerve block with bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of urethrocutaneous fistula
Presence of a urethrocutaneous fistula at postoperative visit up to 1 year after surgery.
Measured: 1 year
Secondary outcomes (3)
Degree of efficacy of caudal block
Blocks will be graded for efficacy using the following scale: Successful, Probably Successful, Probably Failed, or Failed.
Measured: 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
Measured: 1 hour after arrival in PACU post surgery
Need for supplemental analgesics
Administration of opioid in the first postoperative hour will be determined
Measured: 1 hour after arrival in PACU post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start24 May 2017
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Megan Brockel, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861950
- Sponsor's protocol ID
- 15-2343
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2016
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taenzer A, Mandler TN, Gagliardi A, Brockel MA, Vemulakonda V, Pestieau SR, Polaner DM; PRAN Investigators. Caudal versus penile block and urethrocutaneous fistula formation following hypospadias repair in children <2 years: a multicenter randomized clinical trial. Reg Anesth Pain Med. 2026 Sep 11:rapm-2026-108027. doi: 10.1136/rapm-2026-108027. Online ahead of print.
PubMed 42727983
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? A Multi-center Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT02861950
- Acronym / sponsor ID
- 15-2343
- Conditions
- Hypospadias, Urethrocutaneous Fistula
- Keywords
- hypospadias, caudal, urethrocutaneous fistula, penile nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- 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
- Study start
- 24 May 2017 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caudal block | Active comparator | Drug: Caudal block with ropivacainePatients will receive a caudal block with 0.75-1ml/kg of 0.2% ropivacaine. |
| Penile Nerve Block | Active comparator | Drug: penile nerve block with bupivacainePatients will receive a dorsal penile nerve block with up to 0.75ml/kg of 0.25% bupivacaine. |
Who may qualify
- Ages
- 4 months to 2 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants/ children with midshaft or distal hypospadias undergoing primary single stage repair in one of the Pediatric Regional Anesthesia Network participating centers.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caudal block with ropivacainePatients in this arm will receive a caudal block with ropivacaine | Drug | Caudal block |
| penile nerve block with bupivacainePatients in this arm will receive a penile block with bupivacaine | Drug | Penile Nerve Block |
Primary outcome
Incidence of urethrocutaneous fistula
Time frame: 1 year
Presence of a urethrocutaneous fistula at postoperative visit up to 1 year after surgery.
3 secondary outcomes
Degree of efficacy of caudal block
Time frame: 1 hour after arrival in Post Anesthesia Care Unit (PACU) post surgery
Degree of pain
Time frame: 1 hour after arrival in PACU post surgery
Need for supplemental analgesics
Time frame: 1 hour after arrival in PACU post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Derived from this study: PubMed 42727983Taenzer A, Mandler TN, Gagliardi A, Brockel MA, Vemulakonda V, Pestieau SR, Polaner DM; PRAN Investigators. Caudal versus penile block and urethrocutaneous fistula formation following hypospadias repair in children <2 years: a multicenter randomized clinical trial. Reg Anesth Pain Med. 2026 Sep 11:rapm-2026-108027. doi: 10.1136/rapm-2026-108027. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Brockel, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Caudal block with ropivacaine and penile nerve block with bupivacaine in people with Hypospadias and Urethrocutaneous Fistula, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of urethrocutaneous fistula (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02861950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.