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
recommendations by organizations such as the American Society of Anesthesiologists Task
Force on Acute Pain Management and Guidelines from the Society for Pediatric Anesthesia
for alternative pain management, the use of liposomal bupivacaine (EXPAREL®) is a
potential alternative to reduce post-operative pain in the pediatric ABG population.
Liposomal bupivacaine (LB) is an injectable form of bupivacaine used at the surgical site
and that is released over time. Studies have shown that LB better controls pain,
especially during the first 24 hours post-surgery. Better pain control has been
associated with a reduction in opioid usage and its associated complications.
The study is designed to randomize patients to either the standard of care (bupivacaine
with epinephrine) or liposomal bupivacaine with epinephrine to better study pain
management within the first five days after ABG surgery in Shriners' cleft lip and palate
patients.
The FDA approved EXPAREL® for the adult population in 2011 and for the pediatric
population, age 6 years and older in 2021. It is a locally injected single dose analgesia
that is released over 72 hours.
The study is considered minimal risk because LB use does not present an increased risk
over the standard of care (standard bupivacaine) as it is an alternative form of the same
pain medication. Previous studies have shown no additional risk to using the liposomal
version of bupivacaine vs standard bupivacaine in ABG surgeries.
Patients will participate up to 5 days following surgery (surgery day is considered day
0) with reported pain, activity scores, and opioid use collected through either paper,
electronic, or phone questionnaires. Surgeons and patients will be unaware of which
cohort the patient will be randomized to be part of. The pharmacist, anesthesiologist,
and research coordinator may all be aware of which drug is administered.
Researchers will obtain informed consent from the participants and/or their legally
authorized representatives before surgery.