NCT02214810

A Study of Postsurgical Pain Control for Lower Extremity Fractures

A Randomized, Single-blinded, Prospective Study of Postsurgical Pain Control After Open Reduction and Internal Fixation of Lower Extremity Fractures With Liposomal Marcaine.

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Broward Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Lower Extremity Fractures.

Interventions

Type	Name	Description
DRUG	Bupivacaine/Exparel	The opaque envelope, which was selected by the treating physician, will accompany each of the study participants will be opened and the patient identified as belonging to either Group 1 or Group 2. It is important to note that randomization of the envelopes were computer-generated and placed by a co-investigator; the treating physician is completely unaware of the order of the opaque envelopes. Patients in Group 1 will receive a standardized medication regimen including non-liposomal bupivacaine by soft-tissue injection at the conclusion of their surgical procedure. Those in Group 2 will receive non-liposomal bupivacaine and ExparelTM by soft-tissue injection at the conclusion of their surgical procedure. Study participants will undergo injection in this manner until the conclusion of the study.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-08-12
• Last updated: 2016-02-19

Locations

1 site across 1 country: United States