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Caudal vs Penile Nerve Block for Hypospadias Repair
Study Summary
This triallooks at how a caudal block affects a surgery for genital birth defects, to see if it's better or worse than a penile nerve block.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have a certain type of birth defect called proximal or penoscrotal hypospadias.You have an unusual lower back or spinal structure.You have an infection or rash at the location where the injection will be given.You have had surgery for hypospadias in the past.Boys with a particular type of birth defect called hypospadias who are having surgery to fix it at certain hospitals.
- Group 1: Caudal block
- Group 2: Penile Nerve Block
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the research cohort for this study restricted to individuals under 85 years old?
"The allowable age range for applicants to this study is a minimum of 4 Months and an upper limit of 2 Years."
Has Caudal block been granted acknowledgement by the FDA?
"The safety profile of caudal block is rated 3 out of a possible 3, as the treatment has completed Phase 4 trials and been approved."
How is Caudal block commonly deployed to relieve symptoms?
"Caudal block can be leveraged to treat permphigus, as well as acute nonspecific tenosynovitis and general anesthesia. Additionally, this treatment is suitable for expectant mothers during labour."
Who meets the criteria to be eligible to join this research project?
"Candidates for this experiment must have hypospadias and be between 4 months of age to 2 years old. A total of 490 participants are being recruited."
In what other contexts has Caudal block been tested experimentally?
"Currently, 155 active clinical trials for Caudal block are being conducted. 29 of these experiments are in their concluding Phase 3 stage. While the bulk of studies occur near Germantown, Tennessee, there 200 other locations administering this form of therapy."
Is this trial actively seeking participants?
"According to the information visible on clinicaltrials.gov, this trial does not currently require any new participants; it was first listed on May 24th 2017 and most recently updated on January 23rd 2023. However, 281 other studies are actively recruiting right now."
What is the current enrollment capacity for this investigation?
"Unfortunately, this study is not currently recruiting. It was initially posted on May 24th 2017 and its last update occurred in January 23rd 2023. For those looking for other medical trials, hypospadias studies have 126 open positions while Caudal block research has 155 vacancies available at the moment."
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