Liposomal Bupivacaine Use in Alveolar Bone Graft Patients
Kerry O'Rourke
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.
Description
The study is a randomized, double-blinded trial comparing liposomal bupivacaine (EXPAREL®) with epinephrine (0.25%) local anesthetic with the standard treatment of bupivacaine with epinephrine (0.25%) local anesthetic. The study will enroll patients with cleft lip and palate undergoing an alveolar bone graft (ABG) surgery. Researchers will enroll a maximum of 60 patients from Shriners Children's Chicago over a 2-year period. After this surgery, patients experience significant pain. Considering both the frequency of reported pain after ABG combined with the current opioid crisis and subsequent…
Eligibility
- Age range
- 6+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * 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.
Interventions
- DrugLiposomal Bupivacaine
Patients will receive liposomal bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.
- DrugBupivacain
Patients will receive standard bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.
- DrugEpinephrine
Patients will receive epinephrine (ratio of 1:100,000) mixed with the appropriate drug assigned to them based on their arm.
Location
- Shriners Children's ChicagoChicago, Illinois