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Pudendal vs Caudal Block for Pediatric Penile Surgery

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Caudal Block
Pudendal Block
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Nerve Block, Caudal Block, Pudendal Block, Circumcision, Hypospadias, Postoperative Analgesia, Opioid Consumption, Pain Score

Eligibility Criteria

6 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Caudal block

Pudendal Block

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Block failure
Block failure (inability to place block, or block failure based on increase in HR or BP >20% in response to incision)
Intraoperative opioid consumption
Intraoperative opioid consumption during surgery
Time to place the block
The length of time it takes to perform the block on each subject
Time to first analgesic request at home
Time to first analgesic request at home

Full Information

First Posted
April 6, 2021
Last Updated
June 1, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04840654
Brief Title
Pudendal vs Caudal Block for Pediatric Penile Surgery
Official Title
Pudendal vs Caudal Block for Pediatric Penile Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2021 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Nerve Block, Caudal Block, Pudendal Block, Circumcision, Hypospadias, Postoperative Analgesia, Opioid Consumption, Pain Score

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized to 2 groups. One group will receive the Caudal block. The other group will receive the Pudendal block.
Masking
ParticipantOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Caudal block
Arm Type
Active Comparator
Arm Description
This group will receive the Caudal block during their operation (50 patients circumcision, 50 patients hypospadias). This group consist of 100 subjects
Arm Title
Pudendal Block
Arm Type
Active Comparator
Arm Description
This group will receive the Pudendal block during their operation (50 patients circumcision, 50 patients hypospadias). This group consist of 100 subjects
Intervention Type
Procedure
Intervention Name(s)
Caudal Block
Intervention Description
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
Intervention Name(s)
Pudendal Block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Analgesic Consumption
Description
Number of doses of analgesics in the recovery room and in the first 24 hours at home
Time Frame
24 Hours
Secondary Outcome Measure Information:
Title
Postoperative Pain Scores
Description
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.
Time Frame
2 Weeks
Title
Block failure
Description
Block failure (inability to place block, or block failure based on increase in HR or BP >20% in response to incision)
Time Frame
2 Weeks
Title
Intraoperative opioid consumption
Description
Intraoperative opioid consumption during surgery
Time Frame
During Surgery
Title
Time to place the block
Description
The length of time it takes to perform the block on each subject
Time Frame
During Surgery
Title
Time to first analgesic request at home
Description
Time to first analgesic request at home
Time Frame
2 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leili Khorassani, MD
Phone
224-558-7643
Email
lkhorassani@bsd.uchicago.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Edward H Fox
Phone
773-834-5234
Email
efox1@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leili Khorassani, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leili Khorassani, MD
Phone
224-558-7643
Email
lkhorassani@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Al McAuley, BS
Phone
7738343274
Email
amcauley1@bsd.uchicago.edu

12. IPD Sharing Statement

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Pudendal vs Caudal Block for Pediatric Penile Surgery

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