Liposomal Bupivacaine Use in Alveolar Bone Graft Patients
Kerry O'Rourke
60 participants
Apr 24, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- 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.
Exclusion Criteria3
- Patients under age 6 are excluded from this study as EXPAREL® is not FDA approved for this group.
- Patients with a history of allergic or adverse reaction to any drug involved in the study (EXPAREL, Epinephrine, or Bupivacaine).
- Patients with a history of cardiovascular disease.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Patients will receive liposomal bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.
Patients will receive standard bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.
Patients will receive epinephrine (ratio of 1:100,000) mixed with the appropriate drug assigned to them based on their arm.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06284434