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

Femoral Fractures Clinical Trial

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

Status Terminated

Clinical Trial 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 96 hour randomization period with secondary endpoints including total daily opioid requirements for days 1-4, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay.

Clinical Trial Description

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 ;

Related Conditions & MeSH terms

• Acute Pain
• Femoral Fractures
• Fractures, Bone

• NCT number: NCT02679560
• Study type: Interventional
• Source: University of California, Davis
• Status: Terminated
• Phase: Phase 2
• Start date: October 1, 2017
• Completion date: November 1, 2019