Premedication With Melatonin in Lumbar Medial Branch Block Procedure
Condition: Anxiety
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      Chronic low back pain is a common disease in industrialized countries which affect patients'
      productivity and quality of life. Currently, the estimated yearly prevalence of chronic low
      back pain in United States is 5-20%. Lumbar medial branch blocks (LMBB) 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 the LMBB procedure and require intravenous midazolam
      or fentanyl for sedation. In fact, in a retrospective review of over 8,000 interventional
      fluoroscopically guided pain procedures, the highest incidence of vasovagal episodes occurred
      with LMBB procedures. A nurse is required to administer these medications and monitor
      patient's vital signs. In addition, recovery from these medications can unduly prolong the
      patients visit and, in the case of fentanyl, can confound the diagnostic utility of the LMBB
      procedure by decreasing patient's pain.

      In an effort to minimize the cost of administration, monitoring, time of recovery and
      maximize the diagnostic utility of LMBBs, a suitable alternative is required. Several
      randomized, double-blinded, controlled trials investigate the anxiolytic effect of melatonin
      before a surgery. Several other studies and review articles describe the use of melatonin for
      both sedation and anxiolysis in both adults and children. However, no studies to date
      describe the use of melatonin for anxiolysis or sedation for interventional pain medicine
      procedures.

      Melatonin ((N-acetyl-5-methoxytryptamine) is an over-the-counter product which patients can
      take to reduce anxiety before a procedure; it is a hormone produced in the pineal gland and
      secreted into the blood and cerebrospinal fluid. Melatonin has several functions including
      the regulation of circadian rhythms and regulation of the reproductive axis and antioxidant
      activity. Exogenous melatonin has been used to treat insomnia and jet lag.
    

Intervention name(s): 2 mg Melatonin; 10mg Melatonin; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 40 patients will randomly receive 2 mg melatonin; 40 patients will randomly receive 10 mg melatonin; 40 patients will randomly receive a placebo/sugar pill
Other intervention name(s): N-acetyl-5-methoxytripatamin; N-acetyl-5-methoxytripatamin; Sugar Pill
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Melatonin; Lumbar medial branch block (LMBB); Anxiety; Interventional Pain; Pain Procedure