Pudendal vs Caudal Block for Pediatric Penile Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Caudal Block; Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Caudal block; This group will receive the Caudal block during their operation (50 patients circumcision, 50 patients hypospadias). This group consist of 100 subjects	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.
Active Comparator: Pudendal Block; This group will receive the Pudendal block during their operation (50 patients circumcision, 50 patients hypospadias). This group consist of 100 subjects	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic Consumption	Number of doses of analgesics in the recovery room and in the first 24 hours at home	24 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Scores	Analgesia will be evaluated based on the Face, Legs, Activity, Cry, Consolability (FLACC) Scale. This scale has a maximum score of 10 and a minimum score of 0, where the higher the score, the worse outcome. FLACC scores will be recorded in the PACU by the assigned recovery room nurses.	2 Weeks
Block failure	Block failure (inability to place block, or block failure based on increase in HR or BP >20% in response to incision)	2 Weeks
Intraoperative opioid consumption	Intraoperative opioid consumption during surgery	During Surgery
Time to place the block	The length of time it takes to perform the block on each subject	During Surgery
Time to first analgesic request at home	Time to first analgesic request at home	2 Weeks

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Leili Khorassani, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): October 2, 2024
• Study Completion (Actual): October 2, 2024

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Nerve Block; Opioid Consumption; Hypospadias; Postoperative Analgesia; Circumcision; Pain Score; Pudendal Block; Caudal Block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: IRB20-1857

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes