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RECRUITING
NCT06284434
PHASE3

Liposomal Bupivacaine Use in Alveolar Bone Graft Patients

Sponsor: Kerry O'Rourke

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if a pain medication called liposomal bupivacaine (brand name EXPAREL®) with epinephrine will provide better pain control, increased activity, and reduced use of opioids compared with the standard treatment for patients age 6 years and older with cleft lip and palate who have had an alveolar bone graft surgery. Investigators will look at: * pain scores at hip and jaw sites * opioid use in amount and frequency * scores on activity questionnaires Researchers will compare the results of these items with those of patients who had the standard treatment of bupivacaine with epinephrine.

Key Details

Gender

All

Age Range

6 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-04-24

Completion Date

2026-04-24

Last Updated

2024-07-03

Healthy Volunteers

No

Interventions

DRUG

Liposomal Bupivacaine

Patients will receive liposomal bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.

DRUG

Bupivacain

Patients will receive standard bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.

DRUG

Epinephrine

Patients will receive epinephrine (ratio of 1:100,000) mixed with the appropriate drug assigned to them based on their arm.

Locations (1)

Shriners Children's Chicago

Chicago, Illinois, United States