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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study Summary
This trial will study whether ketamine can help relieve pain for those with brachial plexus injuries.
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.Check my eligibility
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.See study design
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 belowSelect...
I have nerve pain scoring over 4 on a specific pain questionnaire.
Select...
I experience severe nerve pain described as burning or electric shocks.
Select...
I have a nerve injury in my shoulder area from a physical trauma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in PROMIS Pain Quality - Neuropathic Pain (PQ-Neuro) score
Secondary outcome measures
Adverse Events
Opioid medication use
Pain Score
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
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,684 Total Patients Enrolled
1 Trials studying Brachial Plexus Injury
20 Patients Enrolled for Brachial Plexus Injury
Alexander Shin, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
159 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for nerve surgery at Mayo Clinic due to pain from a severe arm injury.I have nerve pain scoring over 4 on a specific pain questionnaire.I do not have severe liver issues, heart disease, or uncontrolled schizophrenia.I do not have pain after a severe shoulder nerve injury.I am under 18 years old.You have nerve damage in your spine as shown on a CT myelogram.I do not need surgery on the nerve network near my shoulder.I experience severe nerve pain described as burning or electric shocks.My brachial plexus injury is due to a non-traumatic cause like a tumor or infection.I have a nerve injury in my shoulder area from a physical trauma.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care Group
- Group 2: Ketamine Infusion Group
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for participants to join this research endeavor?
"At present, this specific trial is not accepting patient enrollment. Initially posted on December 15th 2021 and most recently updated on the 29th of that same month, alternative studies may be available for those with brachial plexus injury (888 trials) as well as Ketamine Infusion (105 trials)."
Answered by AI
What is the aggregate figure of participants enrolled in this clinical experiment?
"This clinical trial is now closed to new patient enrolment. It was posted on December 15th 2021 and concluded editing by December 29th 2021. However, there are still 888 studies actively looking for participants with brachial plexus injury and 105 other trials searching for individuals willing to participate in a Ketamine Infusion study."
Answered by AI
Could you elucidate the level of risk associated with Ketamine Infusion?
"As this is a Phase 4 trial with an approved status, the safety of Ketamine Infusion was rated as 3 on our scale."
Answered by AI
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