Premedication With Melatonin in Lumbar Medial Branch Block Procedure

May 11, 2024 updated by: Eugene Smith, United States Naval Medical Center, San Diego

Premedication With Melatonin vs. Placebo in Patients Undergoing Interventional Pain Procedure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92134
        • Pain Medicine Center
    • Virginia
      • Portsmouth, Virginia, United States
        • Naval Medical Center Portsmouth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2 mg Melatonin
To remain within the doses used for anxiolytic effects in past studies, we plan to study the effects of 2mg melatonin.
Drug: 2 mg Melatonin
40 patients will randomly receive 2 mg melatonin
Other Names:
  • N-acetyl-5-methoxytripatamin
Active Comparator: 10 mg Melatonin
To remain within the doses used for anxiolytic effects in past studies, we plan to study the effects of 10mg melatonin.
Drug: 10mg Melatonin
40 patients will randomly receive 10 mg melatonin
Other Names:
  • N-acetyl-5-methoxytripatamin
Placebo Comparator: Sugar Pill
To remain within the doses used for anxiolytic effects in past studies, we plan to study the effects of two different levels of melatonin versus placebo as premedication in patients undergoing a lumbar medial branch block (LMBB) procedure.
Other: Placebo
40 patients will randomly receive a placebo/sugar pill
Other Names:
  • Sugar Pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anxiety level scores as assessed by the data collection sheet given to patients at all three time points (listed below)
Time Frame: Anxiety levels will be assessed at check-in time (90 minutes before procedure), immediately before procedure, and 90 minutes post-operatively.
Comparing melatonin and placebo to see if differing levels of melatonin helps prevent or alleviate anxiety in service members undergoing an interventional pain procedure. For patients participating in the LMBB, anxiety level scores will be compared among the three time-points. Primary analysis will compare the two treatment groups versus placebo. The goal of this study is to demonstrate whether melatonin has anxiolytic effects preoperatively.
Anxiety levels will be assessed at check-in time (90 minutes before procedure), immediately before procedure, and 90 minutes post-operatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Naval Medical Center, San Diego

Investigators

  • Principal Investigator: Rick Fisher, DO, United States Naval Medical Center, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

April 6, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimated)

April 14, 2015

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMCSD.2015.0048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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