Lower Extremity Fractures. Clinical Trial
Official title:
A Randomized, Single-blinded, Prospective Study of Postsurgical Pain Control After Open Reduction and Internal Fixation of Lower Extremity Fractures With Liposomal Marcaine.
Postsurgical pain may effectively be treated with a multimodal approach that incorporates the use of local anesthetics. Bupivacaine is a local anesthetic that has been proven to be effective at reducing postsurgical pain. Furthermore, this local anesthetic has been shown to reduce opioid use, improve functional outcomes, allow for early mobilization, and decrease hospital length of stay. However, local anesthetics, via wound infiltration, are often short-acting and do not meet the duration of postsurgical pain due to their solubility and protein-binding properties. ExparelTM is an FDA-approved liposomal formulation of bupivacaine that allows for 72 hours of postsurgical analgesia with a single injection. This formulation has been shown to have little to no adverse effects; although some studies have reported adverse effects with the use of ExaprelTM, most frequently being nausea, vomiting, and dizziness. The occurrences of these adverse events were still less than the placebo cohort.
All patients undergoing surgical fixation of a lower extremity fracture(s) will be offered
the opportunity to enroll in the study. Patients undergoing unilateral or bilateral surgical
fixation would be included. Written, informed consent to enrollment will be recorded and
included in the patient record. The study is designed around the standard of care for
postsurgical pain management. There are no additional costs to the patient strictly related
to this study.
Patients will undergo surgical fixation of a lower extremity fracture(s) by one of surgical
investigators at a single institution. A sealed, opaque envelope, selected in the
pre-operative holding area, will accompany each patient participant to the operating room.
The envelope will be opened at the conclusion of the fracture fixation to reveal patient
assignment to either study Group 1 or Group 2. Once the total numbers of patients have
completed their procedures and follow-up, the study will close.
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment