The Effect of Adding Magnesium Sulfate to Standard Epidural and Interscalene Block in Treatment of Patients With Chronic Pain

Expanded access is currently available for this treatment.
Verified August 2013 by State University of New York - Upstate Medical University
Sponsor:
Information provided by (Responsible Party):
Shahryar Mousavi, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT01918514
First received: August 5, 2013
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Pain
Drug: Adding Magnesium Sulfate to the standard epidural and interscalene blocks for chronic pain

Study Type: Expanded Access     What is Expanded Access?
Official Title: The Effect of Adding Magnesium Sulfate to Standard Epidural and Interscalene Block in Treatment of Patients With Chronic Pain

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

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):

  1. 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)
  2. 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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant patients
  • Children
  • The rest of exclusion criteria are based on pain clinic protocols for regular injections
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918514

Contacts
Contact: Shahryar Mousavi, MD 3017287094 mousavis@upstate.edu
Contact: Behnam Jafarpour, MD 7033404056 jafapourb@upstate.edu

Locations
United States, New York
Upstate Comprehensive Pain Medicine Center
East Syracuse, New York, United States, 13057
Contact: Shahryar Mousavi, MD    301-728-7094    mousavis@upstate.edu   
Contact: Behnam Jafarpour, MD    7033404056      
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: P. Sebastian Thomas, MD SUNY Upstate UH
  More Information

No publications provided

Responsible Party: Shahryar Mousavi, MD, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT01918514     History of Changes
Other Study ID Numbers: 455904-3
Study First Received: August 5, 2013
Last Updated: August 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
Magnesium sulfate
epidural
interscalene
NMDA receptor

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on September 16, 2014