Ketamine Infusion for Neuralgia

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Disqualifiers: Non-traumatic causes, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Ketamine Infusion for treating neuralgia?

Research shows that ketamine can reduce pain in patients with nerve-related pain conditions, like post-herpetic neuralgia, by decreasing the severity and frequency of pain attacks. Additionally, ketamine has been effective in reducing pain in cancer patients with neuropathic pain when other treatments were not successful. ^{1 2 3 4 5}

Is ketamine infusion generally safe for humans?

Ketamine infusion has been used for pain management and is generally safe at sub-anesthetic doses, but it can cause side effects like nausea, fatigue, dizziness, and injection site pain. Some patients may experience more severe reactions, especially if combined with other substances like magnesium. ^{4 6 7 8 9}

How is ketamine infusion different from other treatments for neuralgia?

Ketamine infusion is unique because it works by blocking NMDA receptors in the brain, which are involved in pain transmission, and is administered continuously through a portable pump, allowing for precise control of dosage. This method can provide significant pain relief for neuralgia, but it may also cause side effects like nausea and dizziness. ^{1 4 10 11 12}

Research Team

Alexander Shin, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion 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.

You have nerve damage in your spine as shown on a CT myelogram.

Exclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ketamine infusion or placebo during surgery and in the 24-hour postoperative period

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with pain measured at various time points up to 6 months post-surgery

6 months

Treatment Details

Interventions

• Ketamine Infusion

Trial Overview 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.

Participant Groups

Group I: Ketamine Infusion Group Experimental Treatment 1 Intervention

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

Group II: Standard of Care Group Active Control 1 Intervention

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

Ketamine Infusion is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ketalar for:

• Anesthesia
• Pain management
• Depression (off-label)

Approved in European Union as Ketanest for:

• Anesthesia
• Pain management

Approved in Canada as Ketamine for:

• Anesthesia
• Pain management

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

A patient with cancer-related neuropathic pain, unresponsive to standard treatments, was successfully treated with intrathecal administration of S(+)-ketamine alongside morphine, indicating its potential as an effective pain management option.

The continuous administration of S(+)-ketamine over 3 months resulted in low plasma levels and no significant side effects, suggesting a favorable safety profile for this treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term intrathecal S(+)-ketamine in a patient with cancer-related neuropathic pain. Benrath, J., Scharbert, G., Gustorff, B., et al.[2018]

A meta-analysis of 12 studies involving 88 patients indicates that Ketamine significantly reduces neuropathic pain compared to placebo, although the effects are typically short-lived after administration.

Ketamine has shown promise as an alternative to opioids for chronic pain management, with some studies reporting positive long-term outcomes, but further research with larger sample sizes is needed to confirm its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ketamine for treatment of chronic pain: meta-analysis]. Wiedemann, B.[2019]

A single preoperative dose of S-ketamine (0.5 mg/kg) did not significantly reduce the incidence of chronic postsurgical pain (CPSP) or acute postoperative pain in patients undergoing video-assisted thoracoscopic surgery (VATS).

However, S-ketamine improved sleep quality on the first postoperative day compared to the placebo, while showing no significant differences in anxiety levels or adverse effects between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single Preoperative Dose of S-Ketamine Has No Beneficial Effect on Chronic Postsurgical Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgical Lung Lesion Resection: A Prospective Randomized Controlled Study. Zhou, R., Zhang, Y., Tang, S., et al.[2023]

Intranasal ketamine is effective for managing acute pain in children, showing similar pain reduction compared to intranasal fentanyl, based on a meta-analysis of 4 trials involving 276 patients.

While ketamine had a higher risk of non-serious adverse events compared to fentanyl, it did not lead to any serious adverse events, making it a potential alternative to opioids for pediatric pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intranasal ketamine for acute pain management in children: A systematic review and meta-analysis. Oliveira J E Silva, L., Lee, JY., Bellolio, F., et al.[2021]

Ketamine has been found to be an effective treatment for chronic pain conditions, including cancer-related neuropathic pain, and can help reduce the need for opioids by counteracting opioid-induced hyperalgesia.

At sub-anesthetic doses, ketamine demonstrates a significantly improved safety profile and fewer adverse events compared to its use as an anesthetic, making it a promising option for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine Use for Cancer and Chronic Pain Management. Culp, C., Kim, HK., Abdi, S.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Long-term intrathecal S(+)-ketamine in a patient with cancer-related neuropathic pain. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

[Ketamine for treatment of chronic pain: meta-analysis]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

A Single Preoperative Dose of S-Ketamine Has No Beneficial Effect on Chronic Postsurgical Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgical Lung Lesion Resection: A Prospective Randomized Controlled Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Continuous subcutaneous administration of the N-methyl-D-aspartic acid (NMDA) receptor antagonist ketamine in the treatment of post-herpetic neuralgia. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Perioperative intravenous S-ketamine for acute postoperative pain in adults: A systematic review and meta-analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Subanesthetic, Subcutaneous Ketamine Infusion Therapy in the Treatment of Chronic Nonmalignant Pain. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Intranasal ketamine for acute pain management in children: A systematic review and meta-analysis. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Ketamine Use for Cancer and Chronic Pain Management. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Magnesium-induced ketamine toxicity. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Slow Infusion of Low-dose Ketamine Reduces Bothersome Side Effects Compared to Intravenous Push: A Double-blind, Double-dummy, Randomized Controlled Trial. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Chronic Pain From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. [2023]

12. France pubmed.ncbi.nlm.nih.gov

[Prevention of psychedelic side effects associated with low dose continuous intravenous ketamine infusion]. [2013]