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Pudendal vs Caudal Block for Pediatric Penile Surgery

Phase 4
Recruiting
Led By Alina Lazar, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children Aged 6 months -3 years Scheduled for elective outpatient circumcision or hypospadias repair
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during surgery
Awards & highlights

Study Summary

This trial will compare how well two types of pain relief work for young children who are having surgery to repair their penis.

Who is the study for?
This trial is for children aged 6 months to 3 years who need outpatient circumcision or hypospadias repair. It's not for kids with spinal issues, a history of heavy painkiller use, kidney problems, bleeding disorders, other surgeries at the same time, wards of the state, non-English speakers or if their caregiver can't follow home instructions.Check my eligibility
What is being tested?
The study compares two types of anesthesia: pudendal block and caudal block in young children having penile surgery. Kids will be randomly chosen to receive one type of block to see which one helps them recover better after surgery.See study design
What are the potential side effects?
While specific side effects are not listed here, both pudendal and caudal blocks may cause typical anesthesia-related side effects such as discomfort at injection site, possible nerve damage risk or localized numbness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child, aged 6 months to 3 years, is scheduled for circumcision or hypospadias repair.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Analgesic Consumption
Secondary outcome measures
Block failure
Intraoperative opioid consumption
Postoperative Pain Scores
+2 more

Trial Design

2Treatment groups
Active Control
Group I: Caudal blockActive Control1 Intervention
This group will receive the Caudal block during their operation (50 patients circumcision, 50 patients hypospadias). This group consist of 100 subjects
Group II: Pudendal BlockActive Control1 Intervention
This group will receive the Pudendal block during their operation (50 patients circumcision, 50 patients hypospadias). This group consist of 100 subjects

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,577 Total Patients Enrolled
Alina Lazar, MDPrincipal InvestigatorUniversity of Chicago
Leili Khorassani, MDPrincipal InvestigatorUniversity of Chicago

Media Library

Caudal Block Clinical Trial Eligibility Overview. Trial Name: NCT04840654 — Phase 4
Postoperative Pain Research Study Groups: Caudal block, Pudendal Block
Postoperative Pain Clinical Trial 2023: Caudal Block Highlights & Side Effects. Trial Name: NCT04840654 — Phase 4
Caudal Block 2023 Treatment Timeline for Medical Study. Trial Name: NCT04840654 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Pudendal Block?

"With the Pudendal Block having been approved, it is assigned a risk score of 3 on our assessment scale. As this is a Phase 4 trial, there have been plenty of data confirming its safety and efficacy."

Answered by AI

May I register for this clinical experiment?

"This experiment seeks to enrol 200 children between 6 months and 3 years of age that are slated for elective outpatient circumcision or hypospadias repair. The required eligibility criteria must be met by each potential participant in order to join the trial."

Answered by AI

Does this experiment accept participants beneath the age of twenty?

"The requirements to join this medical trial specify that patients must be between 6 months and 3 years old. There are 75 studies conducted on participants under 18 and 391 for those over 65."

Answered by AI

Is enrollment still accessible for this research endeavor?

"Based on the data posted to clinicaltrials.gov, this trial is open and actively seeking participants. This medical experimental study was initially declared available in May of 2021 and last updated in November 2022."

Answered by AI

How many subjects have participated in the experiment thus far?

"Affirmative. The data available on clinicaltrials.gov testifies to this medical trial's active recruitment status, which commenced on May 4th 2021 and was most recently updated November 2nd 2022. 200 participants are being sought from a single centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pudendal vs Caudal Block for Pediatric Penile Surgery
2021. "Pudendal vs Caudal Block for Pediatric Penile Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04840654.
~0 spots leftby May 2024
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