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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn about the effect of ketamine on intraoperative motor evoked potentials in adult patients undergoing thoracolumbar spinal fusions. Participants will undergo a standard anesthetic. In addition to the standard anesthetic, the patients will be administered increasing doses of ketamine with motor-evoked potentials being measured at each dose, to assess any impacts.

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.

How is ketamine different from other treatments for spinal fusion?

Ketamine is unique for spinal fusion because it acts as an anesthetic and has pain-relieving properties, which may help manage pain differently compared to traditional pain medications. Unlike other treatments, ketamine works by blocking NMDA receptors in the brain, which can alter pain perception and provide relief. ^{1 2 3 4 5}

Research Team

Marc Buren, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

Analysis of percutaneous kyphoplasty or short-segmental fixation combined with vertebroplasty in the treatment of Kummell disease. [2020]

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

Comparison of Percutaneous Kyphoplasty and Bone Cement-Augmented Short-Segment Pedicle Screw Fixation for Management of Kümmell Disease. [2019]

3. Greece pubmed.ncbi.nlm.nih.gov

Percutaneous kyphoplasty treatment evaluation for patients with Kümmell disease based on a two-year follow-up. [2020]

4. United States 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. [2022]

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

Can Additional Facet Joint Block Improve the Clinical Outcome of Kyphoplasty for Acute Osteoporotic Vertebral Compression Fractures? [2021]