Pre-Operative Ketamine Infusion for Post Operative Pain Control After Revision Spinal Surgery

Description

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.

Conditions

Revision Spine Surgery, Fusion of Spine, Cervical Fusion, Lumbar Fusion

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Study Overview

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Study Details

Study overview

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.

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.

Pre-Operative Ketamine Infusion for Post Operative Pain Control After Revision Spinal Surgery

Condition
Revision Spine Surgery
Intervention / Treatment

-

Contacts and Locations

Coeur d'Alene

AXIS Spine, Coeur d'Alene, Idaho, United States, 83815

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AXIS Spine Center- a division of Northwest Specialty Hospital,

Jessica Jameson, MD, PRINCIPAL_INVESTIGATOR, division of NSWH

Study Record Dates

2024-12