- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04840654
Pudendal vs Caudal Block for Pediatric Penile Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Leili Khorassani, MD
- Phone Number: 224-558-7643
- Email: lkhorassani@bsd.uchicago.edu
Study Contact Backup
- Name: Edward H Fox
- Phone Number: 773-834-5234
- Email: efox1@bsd.uchicago.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago Medical Center
-
Contact:
- Leili Khorassani, MD
- Phone Number: 224-558-7643
- Email: lkhorassani@bsd.uchicago.edu
-
Contact:
- Al McAuley, BS
- Phone Number: 7738343274
- Email: amcauley1@bsd.uchicago.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
|
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
|
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
Time Frame: 24 Hours
|
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
Time Frame: 2 Weeks
|
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
Time Frame: 2 Weeks
|
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
Time Frame: During Surgery
|
Intraoperative opioid consumption during surgery
|
During Surgery
|
Time to place the block
Time Frame: During Surgery
|
The length of time it takes to perform the block on each subject
|
During Surgery
|
Time to first analgesic request at home
Time Frame: 2 Weeks
|
Time to first analgesic request at home
|
2 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leili Khorassani, MD, University of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB20-1857
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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