Baby ORIOLES: Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04826484

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urologic Diseases Hypospadias Undescended Testes Chordee Hydrocele Orchiectomy	Drug: Exparel 133 MG Per 10 ML Injection Drug: Bupivacaine Hydrochloride	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Liposomal Bupivacaine Participants will receive local wound infiltration with Liposomal Bupivacaine.	Drug: Exparel 133 MG Per 10 ML Injection Local wound infiltration with Exparel 133 MG Per 10 ML Injection.
Active Comparator: Standard 0.25% Bupivacaine Participants will receive local wound infiltration with Standard 0.25% Bupivacaine.	Drug: Bupivacaine Hydrochloride Local wound infiltration with 0.25% standard bupivacaine.

Arm

Intervention/Treatment

Experimental: Liposomal Bupivacaine

Participants will receive local wound infiltration with Liposomal Bupivacaine.

Drug: Exparel 133 MG Per 10 ML Injection

Local wound infiltration with Exparel 133 MG Per 10 ML Injection.

Active Comparator: Standard 0.25% Bupivacaine

Participants will receive local wound infiltration with Standard 0.25% Bupivacaine.

Drug: Bupivacaine Hydrochloride

Local wound infiltration with 0.25% standard bupivacaine.

Outcome Measures

Primary Outcome Measures

Percentage of patients who are opiate-free [48 hours postoperatively]
Percentage of patients who are opiate-free at 48 hours postoperatively.
Percentage of patients who are opiate-free [10-14 days postoperatively]
Percentage of patients who are opiate-free at 10-14 days postoperatively.
Parents' postoperative pain measure (PPPM) scores [48 hours postoperatively]
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 [10-14 days postoperatively]
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 [10-14 days postoperatively]
Amount of opioid medication (in OMEQ) used post-discharge.
Amount of opioid medication leftover [10-14 days postoperatively]
Amount of opioid medication (in OMEQ) leftover
Cumulative incidence of complications [10-14 days postoperatively]
Cumulative incidence of complications related to local anesthetic systemic toxicity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator: Heather N DiCarlo, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT04826484

Other Study ID Numbers:

IRB00284462

First Posted:

Apr 1, 2021

Last Update Posted:

Oct 19, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2021