A Study of Postsurgical Pain Control for Lower Extremity Fractures

• Status: Withdrawn
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Broward Health
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Patients over 18 years of age

• Preoperative diagnosis of lower extremity fracture(s) requiring surgical fixation

Exclusion Criteria:

• Allergy to ExparelTM or certain other local anesthetic agents

• Surgery performed at an outside institution or by a different surgeon

• Chronic analgesic users (defined as use of opioid medication >14 days in the past 3 months, or use of non-opioid pain medication >5 times per week

• Pregnant females or females who think they may become pregnant

• Peripheral neuropathy

• Major psychiatric disease

• Inability to comprehend the nature of the study

• Unwillingness to provide signed informed consent

• Markedly abnormal kidney function or renal disease

• Non-English speaking

• Signs or symptoms of compartment syndrome