DOI: 10.1097/oi9.0000000000000504 ISSN: 2574-2167

Liposomal bupivacaine surgical site injection for decrease of narcotic use in hip fractures: a pilot multicenter randomized trial

Paul Edward Matuszewski, Jacob Jo, Arun Aneja, Amna Diwan, Mark T. Kraus, Eric S. Moghadamian, Raymond Dayne Wright, Jodi Siegel, Katherine Thompson, Eric F. Swart
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Abstract

Objectives:

To conduct a pilot randomized control trial evaluating the effectiveness of liposomal bupivacaine to potentially inform a larger trial for effect size and feasibility.

Design:

Double-Blinded Multicenter Randomized Control Trial.

Setting:

Level I trauma centers.

Patients/Participants:

Patients older than 55 years with isolated fragility hip fractures undergoing surgery.

Intervention:

Liposomal bupivacaine (TX) or placebo injection of saline (P).

Main Outcome Measurements:

Morphine milliequivalents at 24, 48, and 72 hours postoperatively. Visual analog scale pain scores, Confusion Assessment Method scores, delirium episodes, and surgical/medical complications were all used as secondary outcomes.

Results:

There were no statistically significant differences in the primary or secondary outcome measures at any time points. Seventy-two-hour opiate use was P: 65.4 mg (95% confidence interval 45.7–85.1) vs TX: 52.5 mg (30.2–74.7), P = 0.37. There was no significant difference in opiate use and visual analog scale scores any time point. There was no difference in Confusion Assessment Method scores or episodes of confusion/delirium nor surgical or medical complications. A 72-hour time point for data collection was not feasible, whereas 48 hours was, with 89% of data points collected. The sample size required for a superiority trial to detect a 20% difference in opioid use would require 518 patients.

Conclusions:

We were unable to demonstrate a clinical difference between liposomal bupivacaine and placebo in narcotic use, pain scores, or postoperative delirium in geriatric fragility fractures. It is possible that there may be a small effect size that we were unable to detect, and a larger study may demonstrate that. However, given the unlikely large improvement in pain, expense of the medication, and technique dependent nature, a smaller difference does not warrant a larger trial nor uniform administration.

Level of Evidence:

Level 1.

Clinical Trial Registration Number:

NCT03289858.

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