Premedication With Melatonin in Lumbar Medial Branch Block Procedure

NCT02415309 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: NMCSD.2015.0048
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Anxiety

Keywords

Melatonin; Lumbar medial branch block (LMBB); Anxiety; Interventional Pain; Pain Procedure

Outcome Measures

Primary Outcomes (1)

• Change in anxiety level scores as assessed by the data collection sheet given to patients at all three time points (listed below)

  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.

Study Arms (3)

2 mg Melatonin

ACTIVE COMPARATOR

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

10 mg Melatonin

ACTIVE COMPARATOR

To remain within the doses used for anxiolytic effects in past studies, we plan to study the effects of 10mg melatonin.

Drug: 10mg Melatonin

Sugar Pill

PLACEBO COMPARATOR

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

Interventions

2 mg Melatonin DRUG

40 patients will randomly receive 2 mg melatonin

Also known as: N-acetyl-5-methoxytripatamin

2 mg Melatonin

10mg Melatonin DRUG

40 patients will randomly receive 10 mg melatonin

Also known as: N-acetyl-5-methoxytripatamin

10 mg Melatonin

Placebo OTHER

40 patients will randomly receive a placebo/sugar pill

Also known as: Sugar Pill

Sugar Pill

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (2)

Pain Medicine Center

San Diego, California, 92134, United States

Location

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Location

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MeSH Terms

Conditions

Anxiety Disorders

Interventions

Melatonin; Sugars

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Carbohydrates

Study Officials

• Rick Fisher, DO

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LCDR, MD

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 14, 2015
• Study Start: July 1, 2016
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)