Caudal Epidural Block and DPNB in Hypospadias (NCT04215874) | Clinical Trial Compass
CompletedNot Applicable
Caudal Epidural Block and DPNB in Hypospadias
Turkey (Türkiye)26 participantsStarted 2019-04-14
Plain-language summary
Hypospadias, seen in every 200-300 births, is one of the most common congenital anomalies of the penis and is defined as the urethral meatus being located in the ventral part of the penis instead of its normal place. The surgery of this anomaly is very painful in the postoperative period and requires long-term analgesia. Regional anesthesia methods combined with general anesthesia play an important role in providing effective and long-term postoperative pain control in pediatric penile surgery. These methods also reduce postoperative morbidity, enable early mobilization and significantly decrease the need for narcotic analgesics.
The investigator's hypothesis is peripheral nerve blocks are superior to neuraxial blocks as the blocks provide longer-term analgesia and have fewer side effects.
Who can participate
Age range
1 Year – 7 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1-7 years of age
* ASA (American Society of Anesthesiologists) I-II group
* Scheduled for distal hypospadias surgery
* Able to communicate in Turkish
* Willing to participate to the study (parents and children)
Exclusion Criteria:
* Less than 1 or more than 7 years of age
* A neurological deficit, bleeding diathesis, or a history of local anesthetic allergy; an infection or redness in the injection area, congenital low back anomaly, liver disorder, a psychiatric disorder, mental retardation, or communication problems detected during examination
* Unwilling to to participate to the study ((parents or children)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time of Postoperative analgesic requirement
Timeframe: Up to 24 hours
Trial details
NCT IDNCT04215874
SponsorProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization