Clinical trial NCT02415309: Premedication With Melatonin in Lumbar Medial Branch Block Procedure
Official title: Premedication With Melatonin vs. Placebo in Patients Undergoing Interventional Pain Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety
Keywords: Melatonin
Lumbar medial branch block (LMBB)
Anxiety
Interventional Pain
Pain Procedure
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2015-04-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* undergoing LMBB procedure
* both genders between the ages of 18-50

Exclusion Criteria:

* patients with active pregnancy (due to ionizing radiation)
* liver disease
* contraindications to LMBB procedure
* patient refusal
* localized or systemic infection
* low platelet count
* fibromyalgia
* use of sedative medications
* failure to comply with procedures
* investigator's determination that the assigned treatment is ineffective or unsafe
* appearance of unacceptable side effects in the subject

Primary outcomes:
measure: Change in anxiety level scores as assessed by the data collection sheet given to patients at all three time points (listed below)
timeFrame: Anxiety levels will be assessed at check-in time (90 minutes before procedure), immediately before procedure, and 90 minutes post-operatively.
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Pain Medicine Center
state: California
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: Rick Fisher, DO
role: PRINCIPAL_INVESTIGATOR
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