20 Participants Needed

Ketamine for Spinal Fusion

MB
Overseen ByMarc Buren, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University of California, San Francisco
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.12345

Who Is on the Research Team?

MB

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?
1Treatment groups
Experimental Treatment
Group I: KetamineExperimental Treatment1 Intervention

Find a Clinic Near You

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.
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.
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.
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]

Citations

Analysis of percutaneous kyphoplasty or short-segmental fixation combined with vertebroplasty in the treatment of Kummell disease. [2020]
Comparison of Percutaneous Kyphoplasty and Bone Cement-Augmented Short-Segment Pedicle Screw Fixation for Management of Kümmell Disease. [2019]
Percutaneous kyphoplasty treatment evaluation for patients with Kümmell disease based on a two-year follow-up. [2020]
Local Anesthetic and Steroid Injection to Relieve the Distal Lumbosacral Pain in Osteoporotic Vertebral Compression Fractures of Patients Treated with Kyphoplasty. [2022]
Can Additional Facet Joint Block Improve the Clinical Outcome of Kyphoplasty for Acute Osteoporotic Vertebral Compression Fractures? [2021]
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