The effect of ketorolac on posterior thoracolumbar spinal fusions: a prospective double-blinded randomised placebo-controlled trial protocol

Chad F Claus, Evan Lytle, Doris Tong, Diana Sigler, Dominick Lago, Matthew Bahoura, Amarpal Dosanjh, Michael Lawless, Dejan Slavnic, Prashant Kelkar, Clifford Houseman, Peter Bono, Boyd Richards, Teck M Soo, Chad F Claus, Evan Lytle, Doris Tong, Diana Sigler, Dominick Lago, Matthew Bahoura, Amarpal Dosanjh, Michael Lawless, Dejan Slavnic, Prashant Kelkar, Clifford Houseman, Peter Bono, Boyd Richards, Teck M Soo

Abstract

Introduction: Ketorolac has been shown to provide quality postoperative pain control and decrease opioid requirement with minimal side effects following spinal surgery. However, the literature addressing its use in spinal fusions is highly variable in both its effectiveness and complications, such as pseudarthrosis. Recent literature postulates that ketorolac may not affect fusion rates and large randomised controlled trials are needed to demonstrate ketorolac as a safe and effective adjuvant treatment to opioids for postoperative pain control.

Methods and analysis: This is a multihospital, prospective, double-blinded, randomised placebo-controlled trial. Data concerning fusion rates, postoperative opioid use, pain scores, length of stay will be recorded with the aim of demonstrating that the use of ketorolac does not decrease thoracolumbar spinal fusion rates while identifying possible adverse events related to short-term minimal effective dose compared with placebo. Additionally, this investigation aims to demonstrate a decrease in postoperative opioid use demonstrated by a decrease in morphine equivalence while showing equivalent postoperative pain control and decrease the average length of stay.

Ethics and dissemination: Ethical approval was obtained at all participating hospitals by the institutional review board. The results of this study will be submitted for publication in peer-reviewed journals.

Trial registration number: NCT03278691.

Keywords: ketorolac; lumbar; non-steroidal anti-inflammatory drugs; opioids; pseudoarthrosis; spinal fusion.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study design Consolidated Standards Of Reporting Trials (CONSORT) flow diagram.

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