Recruiting

Ketamine

Sponsor:

AXIS Spine Center- a division of Northwest Specialty Hospital

Code:

NCT06066879

Conditions

Revision Spine Surgery

Fusion of Spine

Cervical Fusion

Lumbar Fusion

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ketamine Hydrochloride

Study Details

Brief 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.

Conditions

Revision Spine Surgery

Fusion of Spine

Cervical Fusion

Lumbar Fusion

Study ID

NCT06066879

Start date

Sep 18, 2023

Status verified date

Sep, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketamine Infusion

ketamine infusion at 0.5 mg/kg over one hour two weeks (14 days) prior to their scheduled surgical date

no intervention: Standard Of Care

No use of ketamine pre, intra, or post-operatively

Interventions

Ketamine Hydrochloride

Pre-Operative Ketamine infusion

Primary outcome measure

  • Degree of reduction in opiate consumption following surgery [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

AXIS Spine

Recruiting

Coeur d'Alene, Idaho, United States, 83815

Contacts

Principal Investigator:

Jessica Jameson, MD

More Information

Sponsor

AXIS Spine Center- a division of Northwest Specialty Hospital

Last update posted

Oct 4, 2023

Last verified

Sep, 2023

Keywords

  • ketamine
  • revision surgery
  • opioid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AXIS Spine Center- a division of Northwest Specialty Hospital on 2023-10-04.