Pudendal vs Caudal Block for Pediatric Penile Surgery

NCT ID: NCT04840654

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2024-10-02

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Caudal block

This group will receive the Caudal block during their operation (50 patients circumcision, 50 patients hypospadias). This group consist of 100 subjects

Group Type: ACTIVE_COMPARATOR

Caudal Block

Intervention Type: PROCEDURE

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.

Pudendal Block

This group will receive the Pudendal block during their operation (50 patients circumcision, 50 patients hypospadias). This group consist of 100 subjects

Group Type: ACTIVE_COMPARATOR

Pudendal Block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leili Khorassani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

IRB20-1857

Identifier Type: -

Identifier Source: org_study_id