RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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.

Quick Facts

Study Start:2023-09-18
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06066879

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female, aged 18-75
  2. 2. Able to understand the informed consent form and provide written informed consent and able to complete outcome measures
  3. 3. Stated willingness to comply with all study procedures and availability for the duration of the study
  4. 4. Daily opiate use totaling ≥50 morphine milli-equivalents (MME) or more for 6 weeks or greater
  5. 5. Scheduled for revision surgical fusion of the cervical or lumbar spine
  6. 6. Total duration of neck or back pain \>12 weeks
  1. 1. Current use of Ketamine for any other medical conditions
  2. 2. Uncontrolled hypertension
  3. 3. Uncontrolled Diabetes
  4. 4. Increased intracranial pressure
  5. 5. Pregnancy or lactation
  6. 6. Known allergic reactions to components of ketamine or midazolam
  7. 7. Participants who ultimately require intra-operative ketamine administration for anesthesia
  8. 8. Treatment with another investigational drug or other intervention within 12 months of study treatment
  9. 9. History of psychosis or schizophrenia
  10. 10. History of conversion disorder
  11. 11. History of clotting disease
  12. 12. Pending or active compensation claim, litigation or disability remuneration (secondary gain)
  13. 13. Surgically naïve patients
  14. 14. Allergies to any of the medications to be used during the procedures
  15. 15. Active infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved)
  16. 16. Uncontrolled immunosuppression (e.g. AIDS, cancer)
  17. 17. Participating in another clinical trial/investigation within 30 days prior to signing informed consent
  18. 18. Subject unwilling or unable to comply with follow up schedule or protocol requirements

Contacts and Locations

Study Contact

Elisa Maples, BS
CONTACT
2086640290
elisa.maples@nwsh.com

Principal Investigator

Jessica Jameson, MD
PRINCIPAL_INVESTIGATOR
division of NSWH

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: AXIS Spine Center- a division of Northwest Specialty Hospital

  • Jessica Jameson, MD, PRINCIPAL_INVESTIGATOR, division of NSWH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-18
Study Completion Date2024-12

Study Record Updates

Study Start Date2023-09-18
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • ketamine
  • revision surgery
  • opioid

Additional Relevant MeSH Terms

  • Revision Spine Surgery
  • Fusion of Spine
  • Cervical Fusion
  • Lumbar Fusion