Lumbar medial branch blocks are commonly used as a diagnostic tool for facet-mediated chronic
low back pain. This interventional pain procedure often occurs in the fluoroscopy suite.
During this procedure, a physician inserts the needles to deliver local anesthetics such as
lidocaine or bupivacaine to the nerves which innervate the lumbar facet joint. Many patients
experience anxiety before and during the lumbar medial branch block procedure and require
intravenous midazolam or fentanyl for sedation. Intravenous or conscious sedation requires
one-to-one nursing care, monitoring, and recovery. In order to minimize the costs and time
requirements of intravenous sedation, a suitable oral medication which is readily available
and non-controlled would be ideal. Several randomized double-blinded, controlled trials have
investigated the anxiolytic effects of melatonin before a surgery; however no studies to date
have studied the anxiolytic effects of melatonin before less invasive interventional pain
procedures. This study is designed to evaluate the efficacy of melatonin for reducing anxiety
in patients undergoing a lumbar medial branch block procedure.
The study is a randomized, double-blinded, placebo-controlled trial with 40 patients in each
group: 2 mg melatonin, 10 mg melatonin and placebo. The primary outcome is anxiety reduction
in patients before undergoing the procedure. The primary outcome is measured by visual
numerical rating scale for anxiety and the Amsterdam Preoperative Anxiety and Information
Scale. Based on the results of previous studies, the investigators hypothesize that melatonin
may reduce anxiety in patients undergoing the procedure and be a suitable alternative to
intravenous sedation in the pain clinic for patients undergoing lumbar medial branch blocks.