A randomized clinical trial of single dose liposomal bupivacaine versus indwelling analgesic catheter in patients undergoing surgical stabilization of rib fractures - PubMed (original) (raw)

Randomized Controlled Trial

. 2021 Nov 1;91(5):872-878.

doi: 10.1097/TA.0000000000003264.

Christopher Ciarallo, Jonne T H Prins, Candice Preslaski, Elizabeth Perkins-Pride, Kimberly Hardin, Alexis Cralley, Clay Cothren Burlew, Jamie J Coleman, Mitchell J Cohen, Ryan Lawless, K Barry Platnick, Ernest E Moore, Fredric M Pieracci

Affiliations

Randomized Controlled Trial

A randomized clinical trial of single dose liposomal bupivacaine versus indwelling analgesic catheter in patients undergoing surgical stabilization of rib fractures

Kiara N Leasia et al. J Trauma Acute Care Surg. 2021.

Abstract

Introduction: Locoregional analgesia (LRA) remains underused in patients with chest wall injuries. Surgical stabilization of rib fractures (SSRF) offers an opportunity to deliver surgeon-directed LRA under direct visualization at the site of surgical intervention. We hypothesized that a single-dose liposomal bupivacaine (LB) intercostal nerve block provides comparable analgesia to an indwelling, peripheral nerve plane analgesic catheter with continuous bupivacaine infusion (IC), each placed during SSRF.

Methods: Noninferiority, single-center, randomized clinical trial (2017-2020) was performed. Patients were randomized to receive either IC or LB during SSRF. The IC was tunneled into the surgical field (subscapular space), and LB involved thoracoscopic intercostal blocks of ribs 3 to 8. The primary outcome was the Sequential Clinical Assessment of Respiratory Function score, measured daily for 5 days postoperatively. Secondary outcomes included daily narcotic equivalents and failure of primary LRA, defined as requiring a second LRA modality.

Results: Thirty-four patients were enrolled: 16 IC and 18 LB. Age, Injury Severity Score, RibScore, Blunt Pulmonary Contusion Score, and use of nonnarcotic analgesics was similar between groups. Duration of IC was 4.5 days. There were three failures in the IC group versus one in the LB group (p = 0.23). There was no significant difference in Sequential Clinical Assessment of Respiratory Function score between the IC and LB groups. On postoperative days 2 to 4, narcotic requirements were less than half in the LB, as compared with the IC group; however, this difference was not statistically significant. Average wholesale price was US 605forICandUS605 for IC and US 605forICandUS434 for LB.

Conclusion: In this noninferiority trial, LB provided at least comparable and potentially superior LRA as compared with IC among patients undergoing SSRF.

Level of evidence: Therapeutic, level II.

Trial registration: ClinicalTrials.gov NCT03305666.

Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.

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