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

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

Double-Blinded Multicenter Randomized Control Trial.

Level I trauma centers.

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

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

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.

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.

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 1.

NCT03289858.