AnxietyPhase 3NCT02415309
Premedication With Melatonin in Lumbar Medial Branch Block Procedure
A Phase 3 study testing 2 mg Melatonin and 10mg Melatonin in people with Anxiety, run by United States Naval Medical Center, San Diego at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anxiety
- What is being tested?
- 2 mg Melatonin and 10mg Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2016to May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- undergoing LMBB procedure
- both genders between the ages of 18-50
Who cannot join
- patients with active pregnancy (due to ionizing radiation)
- liver disease
- contraindications to LMBB procedure
- patient refusal
- localized or systemic infection
- low platelet count
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Naval Medical Center Portsmouth
Portsmouth, Virginia
Pain Medicine Center
San Diego, California, 92134
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- 2 mg Melatonin, 10mg Melatonin, Placebo
- Keywords
- Melatonin, Lumbar medial branch block (LMBB), Anxiety, Interventional Pain, Pain Procedure
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 mg MelatoninDrug
Also called N-acetyl-5-methoxytripatamin
40 patients will randomly receive 2 mg melatonin
10mg MelatoninDrug
Also called N-acetyl-5-methoxytripatamin
40 patients will randomly receive 10 mg melatonin
PlaceboOther
Also called Sugar Pill
40 patients will randomly receive a placebo/sugar pill
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Anxiety levels will be assessed at check-in time (90 minutes before procedure), immediately before procedure, and 90 minutes post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJul 2016
- Primary completionMay 2022
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Eugene Smith, United States Naval Medical Center, San Diego
- Investigators
- Rick Fisher, DO, Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415309
- Sponsor's protocol ID
- NMCSD.2015.0048
- Status last verified
- May 2024
- First submitted
- 6 Apr 2015
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wheeler AH. Diagnosis and management of low back pain and sciatica. Am Fam Physician. 1995 Oct;52(5):1333-41, 1347-8.
PubMed 7572557Slipman CW, Derby R, Simeone FA, et al. Slipman: Interventional Spine: An Algorithmic Approach, 1st ed. Elsevier Inc 2008.
Wurtman R. Physiology and clinical use of melatonin. www.uptodate.com. Accessed 2/8/15.
Cramer H, Rudolph J, Consbruch U, Kendel K. On the effects of melatonin on sleep and behavior in man. Adv Biochem Psychopharmacol. 1974;11(0):187-91. No abstract available.
PubMed 4367644Wurtman RJ, Zhdanova I. Improvement of sleep quality by melatonin. Lancet. 1995 Dec 2;346(8988):1491. doi: 10.1016/s0140-6736(95)92509-0. No abstract available.
PubMed 7491013Brzezinski A, Vangel MG, Wurtman RJ, Norrie G, Zhdanova I, Ben-Shushan A, Ford I. Effects of exogenous melatonin on sleep: a meta-analysis. Sleep Med Rev. 2005 Feb;9(1):41-50. doi: 10.1016/j.smrv.2004.06.004.
PubMed 15649737Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database Syst Rev. 2002;(2):CD001520. doi: 10.1002/14651858.CD001520.
PubMed 12076414Acil M, Basgul E, Celiker V, Karagoz AH, Demir B, Aypar U. Perioperative effects of melatonin and midazolam premedication on sedation, orientation, anxiety scores and psychomotor performance. Eur J Anaesthesiol. 2004 Jul;21(7):553-7. doi: 10.1017/s0265021504007094.
PubMed 15318468Naguib M, Samarkandi AH. The comparative dose-response effects of melatonin and midazolam for premedication of adult patients: a double-blinded, placebo-controlled study. Anesth Analg. 2000 Aug;91(2):473-9. doi: 10.1097/00000539-200008000-00046.
PubMed 10910871Caumo W, Torres F, Moreira NL Jr, Auzani JA, Monteiro CA, Londero G, Ribeiro DF, Hidalgo MP. The clinical impact of preoperative melatonin on postoperative outcomes in patients undergoing abdominal hysterectomy. Anesth Analg. 2007 Nov;105(5):1263-71, table of contents. doi: 10.1213/01.ane.0000282834.78456.90.
PubMed 17959953Ismail SA, Mowafi HA. Melatonin provides anxiolysis, enhances analgesia, decreases intraocular pressure, and promotes better operating conditions during cataract surgery under topical anesthesia. Anesth Analg. 2009 Apr;108(4):1146-51. doi: 10.1213/ane.0b013e3181907ebe.
PubMed 19299777Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.
PubMed 8623940Melatonin Monograph. http://www.naturaldatabase.com/(S(nqojvt553k2ihb45ojhbdwu1))/nd/Search.aspx?cs=CPCE&s=ND&pt=100&id=940&ds=&name=MELATONIN&searchid=17337409. Accessed 2/3/15.
Ahmad RA, Samarkandi A, Al-Mansouri SM, Obeidan SA. Sedation characteristics of melatonin and midazolam for premedication of adult patients undergoing cataract surgery under local anesthesia. Saudi Journal of Anesthesia 2007;1(1):6.
Bajaj P. Melatonin for anxiolysis in children. Indian J Anaesth 2009;53:504-5.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premedication With Melatonin vs. Placebo in Patients Undergoing Interventional Pain Procedure
- ClinicalTrials.gov ID
- NCT02415309
- Acronym / sponsor ID
- NMCSD.2015.0048
- Conditions
- Anxiety
- Keywords
- Melatonin, Lumbar medial branch block (LMBB), Anxiety, Interventional Pain, Pain Procedure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- Jul 2016
- Primary completion
- May 2022 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 mg Melatonin | Active comparator | Drug: 2 mg MelatoninTo remain within the doses used for anxiolytic effects in past studies, we plan to study the effects of 2mg melatonin. |
| 10 mg Melatonin | Active comparator | Drug: 10mg MelatoninTo remain within the doses used for anxiolytic effects in past studies, we plan to study the effects of 10mg melatonin. |
| Sugar Pill | Placebo comparator | Other: PlaceboTo 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- undergoing LMBB procedure
- both genders between the ages of 18-50
Key exclusion criteria (11 listed)
- patients with active pregnancy (due to ionizing radiation)
- liver disease
- contraindications to LMBB procedure
- patient refusal
- localized or systemic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 mg MelatoninAlso: N-acetyl-5-methoxytripatamin40 patients will randomly receive 2 mg melatonin | Drug | 2 mg Melatonin |
| 10mg MelatoninAlso: N-acetyl-5-methoxytripatamin40 patients will randomly receive 10 mg melatonin | Drug | 10 mg Melatonin |
| PlaceboAlso: Sugar Pill40 patients will randomly receive a placebo/sugar pill | Other | Sugar Pill |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 7572557Wheeler AH. Diagnosis and management of low back pain and sciatica. Am Fam Physician. 1995 Oct;52(5):1333-41, 1347-8.
- BackgroundSlipman CW, Derby R, Simeone FA, et al. Slipman: Interventional Spine: An Algorithmic Approach, 1st ed. Elsevier Inc 2008.
- BackgroundWurtman R. Physiology and clinical use of melatonin. www.uptodate.com. Accessed 2/8/15.
- Background: PubMed 4367644Cramer H, Rudolph J, Consbruch U, Kendel K. On the effects of melatonin on sleep and behavior in man. Adv Biochem Psychopharmacol. 1974;11(0):187-91. No abstract available.
- Background: PubMed 7491013Wurtman RJ, Zhdanova I. Improvement of sleep quality by melatonin. Lancet. 1995 Dec 2;346(8988):1491. doi: 10.1016/s0140-6736(95)92509-0. No abstract available.
- Background: PubMed 15649737Brzezinski A, Vangel MG, Wurtman RJ, Norrie G, Zhdanova I, Ben-Shushan A, Ford I. Effects of exogenous melatonin on sleep: a meta-analysis. Sleep Med Rev. 2005 Feb;9(1):41-50. doi: 10.1016/j.smrv.2004.06.004.
- Background: PubMed 12076414Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database Syst Rev. 2002;(2):CD001520. doi: 10.1002/14651858.CD001520.
- Background: PubMed 15318468Acil M, Basgul E, Celiker V, Karagoz AH, Demir B, Aypar U. Perioperative effects of melatonin and midazolam premedication on sedation, orientation, anxiety scores and psychomotor performance. Eur J Anaesthesiol. 2004 Jul;21(7):553-7. doi: 10.1017/s0265021504007094.
- Background: PubMed 10910871Naguib M, Samarkandi AH. The comparative dose-response effects of melatonin and midazolam for premedication of adult patients: a double-blinded, placebo-controlled study. Anesth Analg. 2000 Aug;91(2):473-9. doi: 10.1097/00000539-200008000-00046.
- Background: PubMed 17959953Caumo W, Torres F, Moreira NL Jr, Auzani JA, Monteiro CA, Londero G, Ribeiro DF, Hidalgo MP. The clinical impact of preoperative melatonin on postoperative outcomes in patients undergoing abdominal hysterectomy. Anesth Analg. 2007 Nov;105(5):1263-71, table of contents. doi: 10.1213/01.ane.0000282834.78456.90.
- Background: PubMed 19299777Ismail SA, Mowafi HA. Melatonin provides anxiolysis, enhances analgesia, decreases intraocular pressure, and promotes better operating conditions during cataract surgery under topical anesthesia. Anesth Analg. 2009 Apr;108(4):1146-51. doi: 10.1213/ane.0b013e3181907ebe.
- Background: PubMed 8623940Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rick Fisher, DO principal investigator
United States Naval Medical Center, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2 mg Melatonin and 10mg Melatonin in people with Anxiety, run by United States Naval Medical Center, San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02415309, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.