What side effects are associated with this type of intervention?

Common treatments for Brachial Plexus Injury include the use of NMDA receptor antagonists like ketamine. Known side effects of ketamine include hallucinations, dizziness, increased blood pressure, and potential for dependency. Other treatments may involve opioids, which carry risks of addiction, respiratory depression, and constipation. Non-opioid analgesics like gabapentin can cause dizziness, fatigue, and peripheral edema. Each treatment option should be carefully considered with a healthcare provider to balance efficacy and potential adverse effects.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for the treatment of Brachial Plexus Injury. However, ketamine, an NMDA receptor antagonist, is being studied for its potential benefits in managing neuropathic pain associated with such injuries. Other treatments for neuropathic pain that have received FDA approval include gabapentinoids (gabapentin and pregabalin) and certain antidepressants (duloxetine and amitriptyline). These drugs are used broadly for various types of neuropathic pain, including those resulting from nerve injuries.

What other types of research exist?

Promising novel alternatives to Ketamine for Brachial Plexus Injury patients include: 1) Gabapentin and Pregabalin, which have shown efficacy in neuropathic pain management. 2) Cannabinoid-based treatments, such as Cannabidiol (CBD), which have been studied for their potential in treating neuropathic pain. 3) Scrambler Therapy, a non-invasive treatment that has shown promise in managing chronic pain conditions. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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NMDA Receptor Antagonist

Ketamine Infusion for Neuralgia

Phase 4

Waitlist Available

Led By Alexander Shin, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Neuropathic pain defined as pain directly related to injury to the somatosensory system, and score >4/10 on the Douleur Neuropathique en 4 Questions (DN4) neuropathic pain questionnaire

Symptoms of neuropathic pain include allodynia, hyperalgesia, burning, needle-like, throbbing, shooting, or electrical-type sensation

Must not have

Contraindication to ketamine use (severe hepatic dysfunction -cirrhosis, high-risk coronary artery disease, poorly controlled psychiatric condition- schizophrenia)

Patients without pain following traumatic brachial plexus injuries

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial is testing if giving ketamine can help reduce severe nerve pain in patients with brachial plexus injuries. Ketamine works by blocking pain signals to the brain. The study aims to see if this reduces the need for other pain medications. Ketamine has been reported to enhance the pain-relieving effects of local anesthetics and is used primarily for patients who are tolerant to opioids and those with severe acute pain.

Who is the study for?

This trial is for adults with severe nerve pain due to traumatic brachial plexus injuries, confirmed by CT myelogram. Participants must experience specific types of neuropathic pain and score over 4/10 on a specialized pain questionnaire. They should be scheduled for surgery at Mayo Clinic. Excluded are those without pain, under 18, not needing surgery, or with conditions like liver disease or schizophrenia that make ketamine use risky.

What is being tested?

The study tests whether ketamine given during surgery can help reduce the intense nerve pain associated with brachial plexus avulsion injuries. It measures patients' neuropathic pain levels before and after their operations to see if there's any improvement.

What are the potential side effects?

Ketamine may cause side effects such as changes in blood pressure and heart rate, dizziness, nausea, hallucinations or unusual thoughts (especially in people with psychiatric conditions), and potential liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have nerve pain scoring over 4 on a specific pain questionnaire.

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I experience severe nerve pain described as burning or electric shocks.

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I have a nerve injury in my shoulder area from a physical trauma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe liver issues, heart disease, or uncontrolled schizophrenia.

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I do not have pain after a severe shoulder nerve injury.

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I am under 18 years old.

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I do not need surgery on the nerve network near my shoulder.

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My brachial plexus injury is due to a non-traumatic cause like a tumor or infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in PROMIS Pain Quality - Neuropathic Pain (PQ-Neuro) score

Secondary study objectives

Adverse Events

Opioid medication use

Pain Score

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ketamine Infusion GroupExperimental Treatment1 Intervention

Subjects will receive ketamine infusion during their planned surgery and postoperatively.

Group II: Standard of Care GroupActive Control1 Intervention

Subjects will receive general anesthesia as standard of care during their planned surgery

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Ketamine, an NMDA receptor antagonist, works by blocking the N-methyl-D-aspartate (NMDA) receptors in the brain and spinal cord, which are involved in pain transmission and central sensitization. This blockade helps reduce neuropathic pain, which is a common and debilitating symptom in Brachial Plexus Injury (BPI) patients. By preventing the excitatory neurotransmitter glutamate from binding to NMDA receptors, ketamine can decrease the hyperexcitability of neurons that contribute to chronic pain. This mechanism is particularly important for BPI patients as it can provide significant pain relief and improve their quality of life, allowing for better participation in rehabilitation and recovery processes.