Pudendal vs Caudal Block for Pediatric Penile Surgery

NCT04840654 | Terminated DMC

• 1 other identifier: IRB20-1857
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Nerve Block; Caudal Block; Pudendal Block; Circumcision; Hypospadias; Postoperative Analgesia; Opioid Consumption; Pain Score

Outcome Measures

Primary Outcomes (1)

• Analgesic Consumption

  Number of doses of analgesics in the recovery room and in the first 24 hours at home

  24 Hours

Secondary Outcomes (5)

• Postoperative Pain Scores

  2 Weeks

• Block failure

  2 Weeks

• Intraoperative opioid consumption

  During Surgery

• Time to place the block

  During Surgery

• Time to first analgesic request at home

  2 Weeks

Study Arms (2)

Caudal block

ACTIVE COMPARATOR

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

Pudendal Block

ACTIVE COMPARATOR

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

Interventions

Caudal Block 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.

Caudal block

Pudendal Block 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.

Pudendal Block

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Hypospadias

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Leili Khorassani, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study will be an observer-blinded RCT. The surgeon, regional pediatric anesthesiologist, and operating room staff (anesthesiologists and nurses) will not be blinded to the treatment group. However, the patient and family, recovery room nurses, and study coordinator who collects the data from families will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to 2 groups. One group will receive the Caudal block. The other group will receive the Pudendal block.

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 12, 2021
• Study Start: May 1, 2021
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

US (1)