Status:

TERMINATED

Pudendal vs Caudal Block for Pediatric Penile Surgery

Lead Sponsor:

University of Chicago

Conditions:

Postoperative Pain

Eligibility:

All Genders

6-3 years

Phase:

NA

Brief Summary

The study will compare recovery profile in children receiving pudendal blocks vs caudal analgesia for ambulatory circumcision or hypospadias repair in children between 6 months and 2 years. The subjec...

Detailed Description

The study participation will begin on the day of surgery and end at the time of last surgical follow-up visit, approximately two weeks later. All procedure related, follow-up clinic visit and PACU dat...

Eligibility Criteria

Inclusion

  • \- Children Aged 6 months -3 years
  • Scheduled for elective outpatient circumcision or hypospadias repair

Exclusion

  • 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

Key Trial Info

Start Date :

May 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 2 2024

Estimated Enrollment :

19 Patients enrolled

Trial Details

Trial ID

NCT04840654

Start Date

May 1 2021

End Date

October 2 2024

Last Update

July 24 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Chicago Medical Center

Chicago, Illinois, United States, 60637