Liposomal Bupivacaine Use in Alveolar Bone Graft Patients

Status unconfirmed · Phase 3

Conditions studied: Cleft Lip and Palate

In brief

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 facts

Study ID

NCT06284434

Run by

Kerry O'Rourke

People needed

60

Starts

2024-04-24

Expected to finish

2026-04-24

Last updated by the study team

2024-07-03

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shriners Children's Chicago — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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