Fusion and Opioid-Sparing With the Use of Ketorolac in Posterior Thoracolumbar Spinal Fusions: A Prospective Double-Blinded Randomized Placebo-Controlled Trial

Abstract

Abstract INTRODUCTION Use of Ketorolac in spinal fusion is limited due to the risk of pseudarthrosis. Recent literature suggested that such an effect could be type and dose-related. We sought to demonstrate that Ketorolac use was safe with significant opioid-sparing effect and non-inferior fusion rate. METHODS This is a prospective, double-blinded, randomized placebo-controlled trial designed according to the 2013 SPIRIT Guidelines. It is a 2-arm parallel design with a 1:1 randomization. Over a 2- period under 6 surgeons at 2 sites, consecutive patients who underwent elective 1 to 3 level minimally invasive thoracolumbar fusion were screened for inclusion/exclusion. Patients with fusion confounders were excluded. A centralized treatment allocation mechanism and Excel-generated block randomization were used. Patients received a 48-hr scheduled treatment of intravenous Ketorolac (15 mg IV Q6H) or saline. We implemented a standardized analgesia regimen using a standardized order set. The primary outcome was fusion as evaluated XR/CT using the Suk criteria at 6/12 mo by a blinded neuroradiologist. The secondary outcomes were morphine-equivalence (MME) in the first 48 hr postop and during the hospital stay, NSAIDs-specific perioperative complications, VAS, length of stay, and quality-of-life outcomes at 6/12 mo. Univariate analysis was used, P < .05 considered significant. The sample size was estimated to be 600. This is an interim analysis to evaluate the safety and MME reduction. RESULTS A total of 142 patients were analyzed. Patient characteristics and operative data were comparable between the groups except EBL. No significant difference in fusion was found at 6-mo. There was a significant reduction in total/48-hr MME and length of stay (LOS) for the ketorolac group. The only complication was a superficial hematoma in a ketorolac-assigned patient requiring evacuation. CONCLUSION Ketorolac demonstrated safety, a significant reduction in postoperative opioid use and length of stay when used as part of a multi-modal analgesic regimen after thoracolumbar fusion.