Ketamine for Spinal Fusion

Overseen By Marc Buren, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of California, San Francisco

Must not be taking: Ketamine

Disqualifiers: Schizophrenia, Hypertension, Myocardial infarction, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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: 30 minutes

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how ketamine, an anesthetic, affects nerve signals during spinal surgery. Researchers aim to determine if ketamine alters the signals that help doctors monitor spinal safety during operations. Candidates for the study include those undergoing thoracolumbar (middle to lower back) spinal fusions, excluding individuals with conditions like schizophrenia or high blood pressure. The study administers ketamine alongside usual anesthesia to observe any effects on nerve signals. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking advancements in spinal surgery safety.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently using ketamine as an outpatient therapy, you cannot participate in this trial.

Is there any evidence suggesting that ketamine is likely to be safe for humans?

Research has shown that ketamine is generally safe for patients undergoing spinal surgeries. One study used low doses of ketamine to manage pain after spinal fusion surgery and found it safe and effective in reducing pain without serious side effects. Ketamine is also commonly used to treat long-term pain and during surgeries to reduce the need for opioids, which are strong painkillers. Although some studies have mixed results, ketamine is considered safe when used in controlled settings like hospitals. This safety record makes ketamine a reliable choice for managing surgical pain. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for spinal fusion, which often involves traditional pain management methods like opioids, ketamine offers a novel approach by targeting the central nervous system in a unique way. Ketamine works as an NMDA receptor antagonist, which may help modulate pain and potentially reduce the need for opioids, a major advantage given the risks associated with opioid use. Researchers are excited about ketamine because it has the potential to provide more effective pain relief while also minimizing side effects and complications commonly associated with current treatments. Additionally, ketamine's rapid onset of action might offer faster pain management during and after surgery, which is a significant benefit over conventional options.

What evidence suggests that ketamine might be an effective treatment for spinal fusion?

Research has shown that ketamine can help reduce pain after spinal fusion surgery. In this trial, all participants will receive ketamine as part of a single treatment arm. Studies have found that administering a low dose of ketamine during surgery can decrease the need for opioids (strong painkillers) afterward by about 38 mg. As a result, patients might experience less pain and recover faster. Ketamine also improves surgery outcomes and shortens hospital stays. Although ketamine may increase some risks, its benefits for managing pain in spinal surgeries are promising. ^{2 6 7 8 9}

Who Is on the Research Team?

Marc Buren, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 years old who are having posterior spinal fusions due to conditions like spinal stenosis or tumors. It's not suitable for those who may have health issues that aren't mentioned but would prevent them from safely receiving ketamine.

Inclusion Criteria

I am over 18 and scheduled for a spinal fusion surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive general anesthesia and increasing doses of ketamine while motor-evoked potentials are measured

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ketamine

Trial Overview The study is testing how different doses of ketamine, given alongside standard anesthesia during surgery, affect the motor signals in patients' muscles (motor evoked potentials) when they're getting thoracolumbar spinal fusion surgery.

How Is the Trial Designed?

Group I: Ketamine Experimental Treatment 1 Intervention

All subjects will be in a single arm. Patients will serve as their own control. Patients will receive general anesthesia in the usual fashion for the indicated procedures. This anesthetic will be standardized between patients. All patients participating in the study will have neuromonitoring as part of their spine surgery as standard care. Baseline motor-evoked potential data will then be collected. Then study drug Ketamine will be administered as following: * Step 1: 0.1 mg/kg bolus over 30 sec followed by infusion of 3mcg/kg/min (0.18 mg/kg/hr) * Step 2: 0.3 mg/kg bolus over 30 sec followed by infusion of 15mcg/kg/min (0.9mg/kg/hr) * Step 3: 0.85 mg/kg bolus over 30 sec followed by infusion at 50mcg/kg/min (3mg/kg/hr) Motor Evoked Potentials will be collected for 5 times at minutes 2, 4, 6, 8, 10 after drug step.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

Both percutaneous kyphoplasty (PKP) and short-segment internal fixation combined with vertebroplasty (SSF + VP) are safe and effective treatments for Kummell disease in patients without neurological deficits, based on an analysis of three retrospective studies.

PKP is particularly advantageous as it significantly reduces operation time and blood loss compared to SSF + VP, making it a preferable option for treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of percutaneous kyphoplasty or short-segmental fixation combined with vertebroplasty in the treatment of Kummell disease. Lu, W., Wang, L., Xie, C., et al.[2020]

Percutaneous kyphoplasty (PKP) significantly reduced pain levels in patients with Kümmell disease, as shown by a decrease in the Visual Analog Scale (VAS) scores from 7.00 pre-surgery to 3.14 at 2 years post-surgery, indicating its efficacy as a treatment.

The study found a positive correlation between the volume of cement injected during PKP and the level of pain relief, suggesting that careful dosing of cement may enhance treatment outcomes, while the procedure was deemed safe with no severe complications reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous kyphoplasty treatment evaluation for patients with Kümmell disease based on a two-year follow-up. Xia, YH., Chen, F., Zhang, L., et al.[2020]

Patients treated with percutaneous kyphoplasty (PKP) showed better early clinical outcomes, including lower pain (VAS) and disability (ODI) scores, compared to those treated with bone cement-augmented short segmental fixation (BCA+SSF).

PKP also resulted in shorter operative times, less blood loss, and shorter hospital stays, while both treatments had similar long-term outcomes and complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Percutaneous Kyphoplasty and Bone Cement-Augmented Short-Segment Pedicle Screw Fixation for Management of Kümmell Disease. Huang, YS., Hao, DJ., Feng, H., et al.[2019]

In a study of 150 patients with osteoporotic vertebral compression fractures, the addition of a local anesthetic and steroid injection during percutaneous kyphoplasty significantly reduced pain and disability in the short term compared to PKP alone, as measured by the visual analog scale (VAS) and Oswestry disability index (ODI) at 1 day, 3 days, 1 week, and 1 month post-surgery.

While the benefits of the local anesthetic and steroid injection were evident in the short term, by 3 months post-operation, there were no significant differences in pain levels or disability between the two groups, indicating that the injection may primarily enhance early recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Anesthetic and Steroid Injection to Relieve the Distal Lumbosacral Pain in Osteoporotic Vertebral Compression Fractures of Patients Treated with Kyphoplasty. Lin, F., Zhang, Y., Wu, T., et al.[2022]

In a study of 194 patients with acute osteoporotic vertebral compression fractures, adding a facet joint block (FJB) to percutaneous kyphoplasty (PKP) significantly improved short-term pain relief and patient satisfaction compared to PKP alone, particularly in the first month post-surgery.

Patients receiving PKP + FJB reported lower Visual Analog Scale (VAS) scores for back pain and better Oswestry Disability Index (ODI) scores, indicating enhanced clinical outcomes, although the benefits were most pronounced shortly after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Additional Facet Joint Block Improve the Clinical Outcome of Kyphoplasty for Acute Osteoporotic Vertebral Compression Fractures? Li, QD., Yang, JS., Gong, HL., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7505386/

Analgesic effects of low-dose ketamine after spinal fusion ... In this double-blind, randomized, prospective study, we assessed the safety and efficacy of intravenous low-dose ketamine for the treatment of pain in patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8989618/

Perioperative Low-Dose Ketamine for Postoperative Pain ... Perioperative low-dose ketamine demonstrated analgesic and morphine-sparing effect with no increased adverse events after spine surgery.

3. journals.lww.com journals.lww.com/neurosurgery/fulltext/2022/04001/187_ketamine_and_spinal_fusion_surgery__does_it.97.aspx

187 Ketamine and Spinal Fusion Surgery: Does It Increase ... We found that intraoperative ketamine administration were associated with lower postoperative opioid consumption -38.35 mg (95% CI -53.18, -23.52), decreased ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/aas.14307

Ketamine for postoperative pain treatment in spinal surgery ... In adults undergoing spinal surgery, ketamine may reduce cumulative 24-h opioid consumption. Ketamine may increase the occurrence of serious adverse events.

5. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04625283?draw=2&rank=1

The Impact of Perioperative Ketamine Infusion on Surgical ... These regimens have been shown to decrease opioid consumption, improve surgical outcomes, and reduce hospital stays, thus coining the term 'enhanced recovery ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9308221/

ketamine hydrochloride injection for postoperative acute pain ... This is a pragmatic, randomized controlled trial which will evaluate the effect of perioperative administration of S(+)-ketamine hydrochloride injection for ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2023/1928969

Application of Ketamine in Pain Management and the ... Ketamine is commonly used to treat various kinds of chronic pain syndromes and is also applied to control perioperative pain and reduce the consumption of ...

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/0976500X221108533

The Effect of Intravenous Ketamine After Spinal Anesthesia ... The results, on the other hand, are mixed. Some studies have shown that ketamine reduces pain scores and, as a result, the need for opioids ...

9. surgicalneurologyint.com surgicalneurologyint.com/wp-content/uploads/2021/04/10751/SNI-12-192.pdf

Effects of ketamine versus dexmedetomidine maintenance ... Conclusion: Both ketamine and dexmedetomidine infusions during maintenance of anesthesia are effective in reducing acute postoperative pain ...