NCT04840654

Pudendal vs Caudal Block for Pediatric Penile Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 6 Months – 3 Years
• Healthy volunteers: Not accepted

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 subjects of the study will be randomized to receive either a caudal or a pudendal block.

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 data will be collected by the research team from the patient's EPIC record (demographic data, pain scores in the PACU, analgesic consumption, time to perform block, time to discharge, etc). Data pertaining to the recovery of patient at home will be collected via phone call or email to the caregiver of the child. Late complications will be identified by reviewing the follow-up surgical note. Questionnaire Administration The physical Pain journal/questionnaires The physical Pain journal/questionnaires will be handed out to the caregiver before discharge from the Post-Anesthesia Care Unit. The caregiver will fill out pain scores at home in the Pain Journal. The pain scores used (FLACC and PPPM) have been extensively validated. In addition, written instructions for using the pain scores to guide pain management interventions at home will be provided. Prior to discharge, caregivers will also be educated by a member of the research team on pain evaluation using the pain score and pain management algorithm. The caregiver will be asked to answer a short questionnaire (Postoperative Parent Survey) about their child pain in the first 24 hours after discharge from the hospital. The caregiver will receive a phone call from the research team 24-48 hours after discharge to retrieve the results of the Pain Journal and Postoperative Pain Survey. Phone Calls Approximately 24-48 hours after the child is discharged from the hospital, a member of the study team will call the caregivers/parents to retrieve the journal responses and check on the health status of the child. During this call, if there are any adverse event that may be related to the block that was performed noted, this will be documented on the AE log and a follow-up phone call will be made approximately 7 days after to verify if the event has ended or is ongoing. Upon learning about any potential related AE, the investigator will determine its severity and relationship to the study procedure and report the event per University of Chicago guidelines.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
PROCEDURE	Caudal Block	A caudal block is a procedure that will help lessen a child's pain after an operation. 100 subjects will be randomized to this block procedure.
PROCEDURE	Pudendal Block	form of local anesthesia commonly used in the practice of obstetrics to relieve pain during the delivery of baby by forceps. 100 Subjects will be randomized to this block procedure.

Timeline

• Start date: 2021-05-01
• Primary completion: 2024-10-02
• Completion: 2024-10-02
• First posted: 2021-04-12
• Last updated: 2025-07-24

Locations

1 site across 1 country: United States