Liposomal Bupivacaine Use in Alveolar Bone Graft Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Healthy Volunteers: f
View:

• Patients that are 6 and older who have a diagnosis of cleft lip and/or palate with a scheduled surgery that involves an alveolar bone graft.

Locations
United States
Illinois
Shriners Children's Chicago
RECRUITING
Chicago
Contact Information
Primary
Chad A. Purnell, MD
cpurnell@shrinenet.org
(724)-433-1645
Backup
Benjamin M. Smith, MS
BenjaminM.Smith@shrinenet.org
(773) 385-5865
Time Frame
Start Date: 2024-04-24
Estimated Completion Date: 2026-04-24
Participants
Target number of participants: 60
Treatments
Experimental: LB Treatment Arm
Patients on the treatment arm will receive liposomal bupivacaine mixed with epinephrine (ratio of 1:100,000), which is not considered the standard of care.
Active_comparator: Bupivacaine Control Arm
Patients on the control arm will follow the current standard of care, which is traditional bupivacaine mixed with epinephrine (1:100,000).
Related Therapeutic Areas
Sponsors
Collaborators: Shriners Hospitals for Children
Leads: Kerry O'Rourke

This content was sourced from clinicaltrials.gov