Liposomal Bupivacaine Use in Alveolar Bone Graft Patients
ConditionCleft Lip and Palate
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6+
SponsorKerry O'Rourke
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Liposomal Bupivacaine
- Bupivacain
- Epinephrine
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Kerry O'Rourke
Lead sponsor
Shriners Hospitals for Children
Sponsor institution
Shriners Hospitals for Children
Collaborator
Source ClinicalTrials.gov