Pudendal vs Caudal Block for Pediatric Penile Surgery

Postoperative Pain Clinical Trial

Official title:

Pudendal vs Caudal Block for Pediatric Penile Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04840654
• Other study ID #: IRB20-1857
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: November 13, 2026

Study information

• Verified date: June 2024
• Source: University of Chicago
• Contact: Leili Khorassani, MD
• Phone: 224-558-7643
• Email: lkhorassani[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 13, 2026
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic Consumption	Number of doses of analgesics in the recovery room and in the first 24 hours at home	24 Hours
Secondary	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
Secondary	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
Secondary	Intraoperative opioid consumption	Intraoperative opioid consumption during surgery	During Surgery
Secondary	Time to place the block	The length of time it takes to perform the block on each subject	During Surgery
Secondary	Time to first analgesic request at home	Time to first analgesic request at home	2 Weeks