Comparing two types of nerve blocks for pain relief in young boys undergoing circumcision or hypospadias repair
Official title: Pudendal vs Caudal Block for Pediatric Penile Surgery
Run by University of Chicago · NCT04840654 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing which type of pain relief, pudendal blocks or caudal analgesia, works better for young boys having circumcision or hypospadias repair.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Months to 3 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04840654 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 6 months to 3 years scheduled for elective outpatient circumcision or hypospadias repair.
✕Probably not a fit
Patients with significant comorbidities, emergency surgeries, or those unable to comply with home pain management instructions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare the effectiveness of pudendal blocks versus caudal analgesia in managing postoperative pain for children aged 6 months to 2 years undergoing elective outpatient circumcision or hypospadias repair. Participants will be randomly assigned to receive one of the two nerve blocks, and their recovery profiles will be monitored through data collected from electronic health records and caregiver feedback. Pain scores will be assessed using validated tools, and caregivers will be educated on pain management strategies before discharge. Follow-up will occur through phone calls to evaluate pain levels and any complications.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for young children undergoing these common surgical procedures.
How similar studies have gone: Previous studies have shown promising results with similar nerve block techniques in pediatric populations, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * - Children Aged 6 months -3 years * Scheduled for elective outpatient circumcision or hypospadias repair Exclusion Criteria: * ASA classification ≥ 3 * emergency surgery * history of a complex regional pain syndrome * sacral dimple * known vertebral spinal abnormalities, spinal dysraphism * history of long-term analgesic use * use of any analgesic (e.g., an opioid medication, acetaminophen, or a nonsteroidal anti-inflammatory agent) within 24 hours before surgery * history of renal insufficiency or a bleeding disorder * concurrent additional surgery at another anatomic site * being a ward of the state * a non-English speaking patient or primary caregiver * inability of the primary caregiver to comply with home instructions
Where it's running
-
University of Chicago Medical Center
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Leili Khorassani, MD — University of Chicago
- Study coordinator: Leili Khorassani, MD
- Email: lkhorassani@bsd.uchicago.edu
- Phone: 224-558-7643
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.