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

Primary Purpose

Pain

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Adding Magnesium Sulfate to the standard epidural and interscalene blocks for chronic pain
Sponsored by
State University of New York - Upstate Medical University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Pain focused on measuring Magnesium sulfate, epidural, interscalene, NMDA receptor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Upstate Comprehensive Pain Medicine Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 5, 2013
Last Updated
October 19, 2021
Sponsor
State University of New York - Upstate Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01918514
Brief Title
The Effect of Adding Magnesium Sulfate to Standard Epidural and Interscalene Block in Treatment of Patients With Chronic Pain
Official Title
The Effect of Adding Magnesium Sulfate to Standard Epidural and Interscalene Block in Treatment of Patients With Chronic Pain
Study Type
Expanded Access

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State University of New York - Upstate Medical University

4. Oversight

5. Study Description

Brief 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. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Magnesium sulfate, epidural, interscalene, NMDA receptor

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Adding Magnesium Sulfate to the standard epidural and interscalene blocks for chronic pain

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P. Sebastian Thomas, MD
Organizational Affiliation
SUNY Upstate UH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Upstate Comprehensive Pain Medicine Center
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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