Clinical Trial: Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures: a Randomized, Active Comparator-controlled, Blinded Trial

Brief Summary: This is an investigator-initiated, single-center, randomized, patient blinded, controlled trial. The purpose of this study is to compare the effect of a fascia iliaca compartment block (FICB) using 0.2% ropivacaine vs. liposomal bupivacaine in patients with femur and/or hip fractures admitted to the University of California Davis Medical Center (UCDMC). The primary endpoint will be the total opioid requirements during the 72 hour randomization period with secondary endpoints including total daily opioid requirements for days 1-3, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay.

Detailed Summary:

In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will result in less total opioid administration during the randomization period compared to a fascia iliaca compartment block using 0.2% ropivacaine.

The long-term goal of this study is to provide pilot information to guide and design larger, multicenter trials which will evaluate the utility and cost-effectiveness of long acting liposomal bupivacaine as an opioid-sparring analgesic strategy in injured trauma patients. Ultimately, it is hoped that this information can improve safe and effective narcotic sparing analgesia in the awake, combat casualty, as well as serve as primary steps towards


Sponsor: University of California, Davis

Current Primary Outcome: Opioid requirements [ Time Frame: During randomization treatment period ]

total opioid requirements during the 72 hour randomization period measured in milligram morphine equivalents


Original Primary Outcome: Same as current

Current Secondary Outcome: Patient outcomes [ Time Frame: During hospital stay ]

total daily opioid requirements for days 1-3, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay


Original Secondary Outcome: Same as current

Information By: University of California, Davis

Dates:
Date Received: February 8, 2016
Date Started: April 2017
Date Completion: August 2017
Last Updated: March 3, 2017
Last Verified: March 2017