Pre-Operative Ketamine Infusion for Post Operative Pain Control After Revision Spinal Surgery
Unknown statusPhase 4NCT06066879
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
To determine if a pre-operative ketamine infusion would provide a similar decrease in post-operative analgesic and opioid consumption as intra-operative ketamine, but expand the monitoring period through the post-operative phase up to 90 days. Hypothesis is that pre-operative ketamine infusion will lead to a decrease in narcotic consumption from baseline following an elective cervical or lumbar fusion, leading to increased functionality and quality of life for these patients.
Study details
- Official title
- 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.
- Conditions
- Revision Spine Surgery
- Fusion of Spine
- Cervical Fusion
- Lumbar Fusion
- Interventions
- Sponsor
- AXIS Spine Center- a division of Northwest Specialty Hospital
- Collaborators
- IDAHO PANHANDLE HEALTH DISTRICT
- Start date
- 2023-09-18
- Primary completion
- 2024-09
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06066879