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

September 28, 2023 updated by: AXIS Spine Center- a division of Northwest Specialty Hospital

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with chronic pain requiring daily opioid use for pain control turn to invasive surgeries for long-term management of their pain, though there is still a chance of requiring opioid pain medications as well as increased use during the immediate post-operative phase. Ketamine infusion peri-operatively has been shown to decrease post-operative pain from invasive surgeries, such as cervical and lumbar fusions, and there is also evidence that ketamine infusions in general can help to improve levels of chronic pain with less need for opioid medications. Our study asks if pre-operative ketamine infusion will decrease overall pain levels following cervical or lumbar surgery through the post-operative phase, decreasing reliance on opioids for daily pain control, as well as improving mood, functionality, and quality of life for patients that live with chronic pain syndromes. Ketamine, an N-methyl-D-aspartate receptor antagonist, has newly received attention for its ability to provide anesthesia in patients with chronic pain syndromes and neuropathic pain syndromes. Recent studies have shown evidence that intra-operative delivery of ketamine can reduce acute post-operative analgesic consumption in patients following a variety of surgical procedures, though this is often focused on the acute post-operative period (initial 72 hours). Additionally, studies have shown that ketamine infusions in patients with chronic pain requiring opioid analgesics does provide some variable level of baseline pain improvement. For patients with chronic neck or back pain, choosing to undergo invasive spinal surgeries potentially could provide some relief of their daily pain, though there is a chance that they will still require daily narcotics for pain relief post-operatively.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83815
        • Recruiting
        • Axis Spine
        • Principal Investigator:
          • Jessica Jameson, MD
        • Contact:

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ketamine Infusion
ketamine infusion at 0.5 mg/kg over one hour two weeks (14 days) prior to their scheduled surgical date
Drug: Ketamine Hydrochloride
Pre-Operative Ketamine infusion
No Intervention: Standard Of Care
No use of ketamine pre, intra, or post-operatively

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Degree of reduction in opiate consumption following surgery
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Responder rate
Time Frame: 12 weeks
The proportion of subjects who experience at least 50% reduction in back pain intensity (improvement in ODI scores) at 3 months as compared with baseline
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AXIS Spine Center- a division of Northwest Specialty Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IDAHO PANHANDLE HEALTH DISTRICT

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jessica Jameson, MD, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KPS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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