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

October 19, 2021 updated by: State University of New York - Upstate Medical University

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

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)

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • East Syracuse, New York, United States, 13057
        • Upstate Comprehensive Pain Medicine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York - Upstate Medical University

Investigators

  • Principal Investigator: P. Sebastian Thomas, MD, SUNY Upstate UH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 5, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (ESTIMATE)

August 7, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 455904-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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