PainNCT01918514
The Effect of Adding Magnesium Sulfate to Standard Epidural and Interscalene Block in Treatment of Patients With Chronic Pain
A study testing Adding Magnesium Sulfate to the standard epidural and interscalene blocks for chronic pain in people with Pain, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
Regional anesthesia is a safe, inexpensive technique, with the advantage of prolonged pain relief. In the pain clinic the investigators perform different injections as the standard treatment for chronic pain based on the diagnosis and indications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Adding Magnesium Sulfate to the standard epidural and interscalene blocks for chronic pain
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patients must be 18 yrs of age and older
- Minimal level of pain of equal or higher than 4 out of 10 on Numerical Rating Scale(NRS=>4)
- The rest of inclusion criteria are based on pain clinic protocols for regular injections
Who cannot join
- Pregnant patients
- Children
- The rest of exclusion criteria are based on pain clinic protocols for regular injections
Trial locations and contacts
1 site in 1 country.
United States1 site
Upstate Comprehensive Pain Medicine Center
East Syracuse, New York, 13057
About this study
Regional anesthesia is a safe, inexpensive technique, with the advantage of prolonged pain relief.
In the pain clinic the investigators perform different injections as the standard treatment for chronic pain based on the diagnosis and indications. Local anesthetic like Bupivacaine with or without Steroids (Depo-medrol) is used for these injections.
The investigators' goal is comparing pain control in different groups adding the magnesium sulfate 100mg to our compounds as an inexpensive, effective, and safe adjuvant to prolong the duration of analgesia and reduce the amount of narcotic dose.
Read the detailed description
N-methyl-D-aspartate(NMDA) receptors are fundamental factors in controlling synaptic plasticity and memory function and play an important role in transition of acute pain to chronic intractable pain.
Magnesium is physiologic NMDA receptor antagonist. It will stabilized NMDA receptor and prevents influx of calcium and sodium ion. It has been studied that serum magnesium level is low in patients with chronic pain. Several studies has been done and shown that Magnesium has a significant effect in neuroprotection and membrane stabilization. Blocking the NMDA receptor will prevent activation of first order neurons in periphery or second order neurons in dorsal horn of spinal cord and then higher pain pathways to third order neurons and centers of the pain perception. Topical, oral and more effectively intravenous administration of magnesium has been used widely in treatment of chronic pain. There are limitations of intravenous administration of magnesium secondary to systemic cardiovascular side effects.
In several standardized study it has been shown that using magnesium intrathecally, epidurally or with interscalene injections can boost up the effect of opioids or local anesthetics. At the dose of 100 mg, it has been safe and effective to use.
Regional anesthesia is a safe, inexpensive technique, with the advantage of prolonged pain relief.
In the pain clinic the investigators perform different injections as the standard treatment for chronic pain based on the diagnosis and indications. Local anesthetic like Bupivacaine with or without Steroids (Depo-medrol) is used for these injections.
The investigators' goal is comparing pain control in different groups adding the magnesium sulfate 100mg to our compounds as an inexpensive, effective, and safe adjuvant to prolong the duration of analgesia and reduce the amount of narcotic dose. The investigators want to conduct a prospective, randomized, double-blind placebo controlled study with two major injections (2 different studies with the same concept):
- Interscalene injection (2 subgroups including A: with Bupivacaine 0.25%(20ml) which is the standard injection with 1ml saline as placebo vs B: Bupivacaine 0.25%(20ml)+ Magnesium sulfate (100mg in 1 ml)
- Epidural injection(2 subgroups including A:Bupivacaine 0.125%(8ml)+ Depo medrol(80mg) as the standard injection with 1ml saline as placebo vs B: Bupivacaine 0.125%(8ml)+ Depo medrol(80mg)+ Magnesium sulfate (100mg in 1 ml)
- Conditions
- Pain
- Being tested
- Adding Magnesium Sulfate to the standard epidural and interscalene blocks for chronic pain
- Keywords
- Magnesium sulfate, epidural, interscalene, NMDA receptor
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adding Magnesium Sulfate to the standard epidural and interscalene blocks for chronic painDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- P. Sebastian Thomas, MD, Principal investigator, SUNY Upstate UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918514
- Sponsor's protocol ID
- 455904-3
- Status last verified
- Aug 2013
- First submitted
- 5 Aug 2013
- Last updated
- 22 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Magnesium Sulfate to Standard Epidural and Interscalene Block in Treatment of Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT01918514
- Acronym / sponsor ID
- 455904-3
- Conditions
- Pain
- Keywords
- Magnesium sulfate, epidural, interscalene, NMDA receptor
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- First posted
- 7 Aug 2013 (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.
Regional anesthesia is a safe, inexpensive technique, with the advantage of prolonged pain relief.
In the pain clinic the investigators perform different injections as the standard treatment for chronic pain based on the diagnosis and indications. Local anesthetic like Bupivacaine with or without Steroids (Depo-medrol) is used for these injections.
The investigators' goal is comparing pain control in different groups adding the magnesium sulfate 100mg to our compounds as an inexpensive, effective, and safe adjuvant to prolong the duration of analgesia and reduce the amount of narcotic dose.
Detailed description
N-methyl-D-aspartate(NMDA) receptors are fundamental factors in controlling synaptic plasticity and memory function and play an important role in transition of acute pain to chronic intractable pain.
Magnesium is physiologic NMDA receptor antagonist. It will stabilized NMDA receptor and prevents influx of calcium and sodium ion. It has been studied that serum magnesium level is low in patients with chronic pain. Several studies has been done and shown that Magnesium has a significant effect in neuroprotection and membrane stabilization. Blocking the NMDA receptor will prevent activation of first order neurons in periphery or second order neurons in dorsal horn of spinal cord and then higher pain pathways to third order neurons and centers of the pain perception. Topical, oral and more effectively intravenous administration of magnesium has been used widely in treatment of chronic pain. There are limitations of intravenous administration of magnesium secondary to systemic cardiovascular side effects.
In several standardized study it has been shown that using magnesium intrathecally, epidurally or with interscalene injections can boost up the effect of opioids or local anesthetics. At the dose of 100 mg, it has been safe and effective to use.
Regional anesthesia is a safe, inexpensive technique, with the advantage of prolonged pain relief.
In the pain clinic the investigators perform different injections as the standard treatment for chronic pain based on the diagnosis and indications. Local anesthetic like Bupivacaine with or without Steroids (Depo-medrol) is used for these injections.
The investigators' goal is comparing pain control in different groups adding the magnesium sulfate 100mg to our compounds as an inexpensive, effective, and safe adjuvant to prolong the duration of analgesia and reduce the amount of narcotic dose. The investigators want to conduct a prospective, randomized, double-blind placebo controlled study with two major injections (2 different studies with the same concept):
- Interscalene injection (2 subgroups including A: with Bupivacaine 0.25%(20ml) which is the standard injection with 1ml saline as placebo vs B: Bupivacaine 0.25%(20ml)+ Magnesium sulfate (100mg in 1 ml)
- Epidural injection(2 subgroups including A:Bupivacaine 0.125%(8ml)+ Depo medrol(80mg) as the standard injection with 1ml saline as placebo vs B: Bupivacaine 0.125%(8ml)+ Depo medrol(80mg)+ Magnesium sulfate (100mg in 1 ml)
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be 18 yrs of age and older
- Minimal level of pain of equal or higher than 4 out of 10 on Numerical Rating Scale(NRS=>4)
- The rest of inclusion criteria are based on pain clinic protocols for regular injections
Key exclusion criteria (3 listed)
- Pregnant patients
- Children
- The rest of exclusion criteria are based on pain clinic protocols for regular injections
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 |
|---|---|---|
| Adding Magnesium Sulfate to the standard epidural and interscalene blocks for chronic pain | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
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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.
P. Sebastian Thomas, MD principal investigator
SUNY Upstate UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adding Magnesium Sulfate to the standard epidural and interscalene blocks for chronic pain in people with Pain, run by State University of New York - Upstate Medical University at 1 site 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 22 Oct 2021.