Premedication With Melatonin in Lumbar Medial Branch Block Procedure
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Anxiety, Anxiety |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | February 2016 |
| End Date: | September 2017 |
| Contact: | Ian M Fowler, MD |
| Email: | ian.m.fowler.mil@mail.mil |
| Phone: | 619-532-8943 |
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.
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.
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.
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.
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
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