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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AXIS Spine Center- a division of Northwest Specialty Hospital
• Collaborator: IDAHO PANHANDLE HEALTH DISTRICT
• Treatments: Ketamine

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