Back to resultsOpioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel (Baby ORIOLES)
Primary Purpose
Urologic Diseases, Hypospadias, Undescended Testes
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Exparel 133 miligrams per 10 milliliter injection
Bupivacaine Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Urologic Diseases
Eligibility Criteria
Inclusion Criteria:
- Pediatric patients 6 years and older undergoing minor pediatric urologic surgery
- Patients who are otherwise eligible to receive routine care following minor urologic surgery
Exclusion Criteria:
- Contraindication to receiving local anesthetics (i.e. pre-existing cardiac, renal, hepatic dysfunction)
- Pediatric patients younger than 6 years of age
- Pediatric patients with a history of pain syndromes or are unable to tolerate opiate medication
- Unwilling to participate in 48 hours and 10-14 day follow-up phone calls
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Liposomal Bupivacaine plus 0.25% Bupivacaine
0.25% Bupivacaine alone
Arm Description
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
Outcomes
Primary Outcome Measures
Percentage of patients who are opiate-free
Percentage of patients who are opiate-free at 48 hours postoperatively.
Percentage of patients who are opiate-free
Percentage of patients who are opiate-free at 10-14 days postoperatively.
Parents' postoperative pain measure (PPPM) scores
15-item, yes/no behavioral checklist based on non-verbal pain cues children show following surgery. Scale is from 0 to 15, with higher scores denoting more severe pain. A score of 6+ has been validated as a threshold for a child experiencing clinically significant pain.
Parents' postoperative pain measure (PPPM) scores
15-item, yes/no behavioral checklist based on non-verbal pain cues children show following surgery. Scale is from 0 to 15, with higher scores denoting more severe pain. A score of 6+ has been validated as a threshold for a child experiencing clinically significant pain.
Secondary Outcome Measures
Amount of opioid medication used post-discharge
Amount of opioid medication (in OMEQ) used post-discharge.
Amount of opioid medication leftover
Amount of opioid medication (in OMEQ) leftover
Cumulative incidence of complications
Cumulative incidence of complications related to local anesthetic systemic toxicity.
Full Information
NCT ID
NCT04826484
First Posted
March 29, 2021
Last Updated
April 26, 2023
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT04826484
Brief Title
Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel
Acronym
Baby ORIOLES
Official Title
A Randomized Trial Evaluating Use of Long-Acting Liposomal Bupivacaine (Exparel®) in Reducing Narcotic Pain Requirements in Pediatric Patients Undergoing Minor Urologic Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Met futility threshold at interim analysis
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
April 26, 2023 (Actual)
Study Completion Date
April 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to evaluate the utility of long-acting liposomal bupivacaine (Exparel®) in improving pain scores and reducing narcotic pain requirements in pediatric patients following minor urologic procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Diseases, Hypospadias, Undescended Testes, Chordee, Hydrocele, Orchiectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liposomal Bupivacaine plus 0.25% Bupivacaine
Arm Type
Experimental
Arm Description
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
Arm Title
0.25% Bupivacaine alone
Arm Type
Active Comparator
Arm Description
Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
Intervention Type
Drug
Intervention Name(s)
Exparel 133 miligrams per 10 milliliter injection
Intervention Description
Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
Local wound infiltration with 0.25% bupivacaine.
Primary Outcome Measure Information:
Title
Percentage of patients who are opiate-free
Description
Percentage of patients who are opiate-free at 48 hours postoperatively.
Time Frame
48 hours postoperatively
Title
Percentage of patients who are opiate-free
Description
Percentage of patients who are opiate-free at 10-14 days postoperatively.
Time Frame
10-14 days postoperatively
Title
Parents' postoperative pain measure (PPPM) scores
Description
15-item, yes/no behavioral checklist based on non-verbal pain cues children show following surgery. Scale is from 0 to 15, with higher scores denoting more severe pain. A score of 6+ has been validated as a threshold for a child experiencing clinically significant pain.
Time Frame
48 hours postoperatively
Title
Parents' postoperative pain measure (PPPM) scores
Description
15-item, yes/no behavioral checklist based on non-verbal pain cues children show following surgery. Scale is from 0 to 15, with higher scores denoting more severe pain. A score of 6+ has been validated as a threshold for a child experiencing clinically significant pain.
Time Frame
10-14 days postoperatively
Secondary Outcome Measure Information:
Title
Amount of opioid medication used post-discharge
Description
Amount of opioid medication (in OMEQ) used post-discharge.
Time Frame
10-14 days postoperatively
Title
Amount of opioid medication leftover
Description
Amount of opioid medication (in OMEQ) leftover
Time Frame
10-14 days postoperatively
Title
Cumulative incidence of complications
Description
Cumulative incidence of complications related to local anesthetic systemic toxicity.
Time Frame
10-14 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pediatric patients 6 years and older undergoing minor pediatric urologic surgery
Patients who are otherwise eligible to receive routine care following minor urologic surgery
Exclusion Criteria:
Contraindication to receiving local anesthetics (i.e. pre-existing cardiac, renal, hepatic dysfunction)
Pediatric patients younger than 6 years of age
Pediatric patients with a history of pain syndromes or are unable to tolerate opiate medication
Unwilling to participate in 48 hours and 10-14 day follow-up phone calls
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather N DiCarlo, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel
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