Using ketamine before surgery to reduce pain after spinal surgery
Non Randomized Cohort Study to Evaluate Pre-operative Ketamine Infusion for the Decrease Overall Pain Levels Following Revision Cervical or Lumbar Fusion Surgery Through the Post-operative Phase, Decreasing Reliance on Opioids for Daily Pain Control, Opioid Related Adverse Events, as Well as Improving Mood, Functionality, and Quality of Life for Patients That Live With Chronic Pain Syndromes.
This study is testing if giving ketamine before spinal surgery can help reduce pain and the need for opioids after the surgery for patients with chronic pain.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | AXIS Spine Center- a division of Northwest Specialty Hospital Academic / other |
| Locations | 1 site (Coeur d'Alene, Idaho) |
| Trial ID | NCT06066879 on ClinicalTrials.gov |
What this trial studies
This study investigates whether a pre-operative infusion of ketamine can effectively reduce post-operative pain and opioid consumption in patients undergoing revision spinal surgery. The research aims to monitor patients for up to 90 days post-surgery to assess the impact of ketamine on pain levels and overall functionality. By focusing on patients with chronic pain who require significant opioid use, the study seeks to determine if ketamine can improve quality of life and reduce reliance on narcotics after cervical or lumbar fusion procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have chronic pain requiring daily opioid use and are scheduled for revision spinal fusion surgery.
Not a fit: Patients with uncontrolled medical conditions, current ketamine use for other conditions, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly decrease opioid use and improve recovery outcomes for patients undergoing spinal surgery.
How similar studies have performed: Previous studies have shown that intra-operative ketamine can reduce post-operative pain, suggesting potential success for this pre-operative approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female, aged 18-75 2. Able to understand the informed consent form and provide written informed consent and able to complete outcome measures 3. Stated willingness to comply with all study procedures and availability for the duration of the study 4. Daily opiate use totaling ≥50 morphine milli-equivalents (MME) or more for 6 weeks or greater 5. Scheduled for revision surgical fusion of the cervical or lumbar spine 6. Total duration of neck or back pain \>12 weeks Exclusion Criteria: 1. Current use of Ketamine for any other medical conditions 2. Uncontrolled hypertension 3. Uncontrolled Diabetes 4. Increased intracranial pressure 5. Pregnancy or lactation 6. Known allergic reactions to components of ketamine or midazolam 7. Participants who ultimately require intra-operative ketamine administration for anesthesia 8. Treatment with another investigational drug or other intervention within 12 months of study treatment 9. History of psychosis or schizophrenia 10. History of conversion disorder 11. History of clotting disease 12. Pending or active compensation claim, litigation or disability remuneration (secondary gain) 13. Surgically naïve patients 14. Allergies to any of the medications to be used during the procedures 15. Active infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved) 16. Uncontrolled immunosuppression (e.g. AIDS, cancer) 17. Participating in another clinical trial/investigation within 30 days prior to signing informed consent 18. Subject unwilling or unable to comply with follow up schedule or protocol requirements
Where this trial is running
Coeur d'Alene, Idaho
- AXIS Spine — Coeur d'Alene, Idaho, United States (Recruiting)
Study contacts
- Principal investigator: Jessica Jameson, MD — division of NSWH
- Study coordinator: Elisa Maples, BS
- Email: elisa.maples@nwsh.com
- Phone: 2086640290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.