Revision Spine SurgeryPhase 4KIPSsNCT06066879
Pre-Operative Ketamine Infusion for Post Operative Pain Control After Revision Spinal Surgery
A Phase 4 study testing Ketamine Hydrochloride in people with Revision Spine Surgery and Fusion of Spine, run by AXIS Spine Center- a division of Northwest Specialty Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Revision Spine Surgery, Fusion of Spine, Cervical Fusion
- What is being tested?
- Ketamine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18-75
- Able to understand the informed consent form and provide written informed consent and able to complete outcome measures
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Daily opiate use totaling ≥50 morphine milli-equivalents (MME) or more for 6 weeks or greater
- Scheduled for revision surgical fusion of the cervical or lumbar spine
- Total duration of neck or back pain >12 weeks
Who cannot join
- Current use of Ketamine for any other medical conditions
- Uncontrolled hypertension
- Uncontrolled Diabetes
- Increased intracranial pressure
- Pregnancy or lactation
- Known allergic reactions to components of ketamine or midazolam
Show all 18Show fewer
- Participants who ultimately require intra-operative ketamine administration for anesthesia
- Treatment with another investigational drug or other intervention within 12 months of study treatment
- History of psychosis or schizophrenia
- History of conversion disorder
- History of clotting disease
- Pending or active compensation claim, litigation or disability remuneration (secondary gain)
- Surgically naïve patients
- Allergies to any of the medications to be used during the procedures
- Active infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved)
- Uncontrolled immunosuppression (e.g. AIDS, cancer)
- Participating in another clinical trial/investigation within 30 days prior to signing informed consent
- Subject unwilling or unable to comply with follow up schedule or protocol requirements
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
AXIS Spine
Coeur d'Alene, Idaho, 83815
Elisa Maples, 208-664-0290, elisa.maples@nwsh.com
Jessica Jameson, MD
About this study
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.
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.
Read the 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.
- Being tested
- Ketamine Hydrochloride
- Keywords
- ketamine, revision surgery, opioid
- Medical subject headings
- Klippel-Feil Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Pre-Operative Ketamine infusion
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Infusion | Experimental | ketamine infusion at 0.5 mg/kg over one hour two weeks (14 days) prior to their scheduled surgical date Receives: Drug: Ketamine Hydrochloride |
| Standard Of Care | No intervention | No use of ketamine pre, intra, or post-operatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of reduction in opiate consumption following surgery
Measured: 12 weeks
Secondary outcomes (1)
Responder rate
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start18 Sep 2023
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revision Spine SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AXIS Spine Center- a division of Northwest Specialty Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- IDAHO PANHANDLE HEALTH DISTRICT
- Responsible party
- Sponsor
- Investigators
- Jessica Jameson, MD, Principal investigator, division of NSWH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066879
- Sponsor's protocol ID
- KPS001
- Acronym
- KIPSs
- Status last verified
- Sep 2023
- First submitted
- 28 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06066879
- Acronym / sponsor ID
- KIPSs / KPS001
- Keywords
- ketamine, revision surgery, opioid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AXIS Spine Center- a division of Northwest Specialty HospitalUniversity, hospital or other
- Collaborators
- IDAHO PANHANDLE HEALTH DISTRICT
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Infusion | Experimental | Drug: Ketamine Hydrochlorideketamine infusion at 0.5 mg/kg over one hour two weeks (14 days) prior to their scheduled surgical date |
| Standard Of Care | No intervention | –No use of ketamine pre, intra, or post-operatively |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, aged 18-75
- Able to understand the informed consent form and provide written informed consent and able to complete outcome measures
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Daily opiate use totaling ≥50 morphine milli-equivalents (MME) or more for 6 weeks or greater
- Scheduled for revision surgical fusion of the cervical or lumbar spine
Key exclusion criteria (18 listed)
- Current use of Ketamine for any other medical conditions
- Uncontrolled hypertension
- Uncontrolled Diabetes
- Increased intracranial pressure
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine HydrochloridePre-Operative Ketamine infusion | Drug | Ketamine Infusion |
Primary outcome
Degree of reduction in opiate consumption following surgery
Time frame: 12 weeks
1 secondary outcome
Responder rate
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Revision Spine Surgery
Active, not recruiting
Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
Failed Back Surgery Syndrome, Degeneration Lumbar Spine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Jameson, MD principal investigator
division of NSWH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine Hydrochloride in people with Revision Spine Surgery and Fusion of Spine, run by AXIS Spine Center- a division of Northwest Specialty Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisa Maples, BS (2086640290, elisa.maples@nwsh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of reduction in opiate consumption following surgery (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.