The Patient-Reported Outcomes of Postoperative Prostaglandin E1 Derivative in Lumbar Spine Surgery: A Randomized, Double-Blind, Controlled Trial.

Abstract

Study DesignA Randomized, Double-Blind, Controlled Trial.ObjectivePostoperative residual leg numbness is a common complication following decompressive and fusion lumbar spine surgery. Prostaglandin E1 derivatives, such as limaprost, have demonstrated efficacy in reducing leg numbness in non-surgical populations. However, evidence regarding the efficacy of limaprost in post-surgical patients remains limited. This randomized controlled trial aimed to compare patient-reported outcomes between postoperative limaprost and placebo treatment.MethodsSixty patients diagnosed with degenerative lumbar spine disease and undergoing one or two levels of decompressive and fusion lumbar spine surgery were randomized to receive either postoperative limaprost or placebo for 6 months. Primary outcome evaluation was leg numbness severity, as assessed using the Visual Analog Scale (VAS). Secondary outcomes included tingling sensation, back pain, leg pain, the Oswestry Disability Index (ODI), and the EuroQol-5D (EQ-5D).ResultsBaseline demographic characteristics and patient-reported outcomes were comparable between the two groups. Both groups exhibited significant reductions in leg numbness at all postoperative time points (<i>P</i> < 0.001). However, no significant difference in leg numbness scores was observed between limaprost and placebo groups (<i>P</i> = 0.5). Notably, patients in limaprost group exhibited significantly greater reductions in back pain compared to the placebo group over the entire follow-up period (<i>P</i> < 0.001). No clinically significant differences were observed between groups for other patient-reported outcomes.ConclusionPostoperative limaprost did not result in a significant reduction in leg numbness compared to placebo. Nevertheless, limaprost may offer potential benefits in alleviating back pain following decompressive and fusion lumbar spine surgery.