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Ketamine for Postoperative Pain After Spinal Surgery (KIPSs Trial)

Phase 4
Recruiting
Led By Jessica Jameson, MD
Research Sponsored by AXIS Spine Center- a division of Northwest Specialty Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled for revision surgical fusion of the cervical or lumbar spine
Total duration of neck or back pain >12 weeks
Must not have
Uncontrolled Diabetes
Current use of Ketamine for any other medical conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial tests if pre-op ketamine infusion can reduce post-op opioid use and improve recovery and quality of life for patients having cervical or lumbar fusion.

Who is the study for?
This trial is for adults aged 18-75 who are scheduled for revision spinal fusion surgery and have been using opioids daily. They must understand the study, agree to its procedures, and not be on ketamine or other investigational drugs. People with uncontrolled hypertension, diabetes, certain mental health conditions, clotting diseases, active infections or claims related to disability cannot participate.
What is being tested?
The study tests if a pre-operative infusion of Ketamine Hydrochloride can reduce pain and opioid use after cervical or lumbar spine surgery. The effect will be monitored up to 90 days post-surgery with the aim of improving functionality and quality of life.
What are the potential side effects?
Ketamine may cause side effects such as nausea, vomiting, hallucinations, increased blood pressure and heart rate changes. It might also lead to mood swings or dizziness but varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a repeat surgery on my neck or lower back.
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I have had neck or back pain for more than 12 weeks.
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I have been using daily pain medication equivalent to 50 or more morphine units for over 6 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My diabetes is not under control.
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I am currently using Ketamine for a medical condition.
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My blood pressure is not controlled by medication.
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I will need ketamine for anesthesia during my surgery.
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I have never undergone surgery.
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I do not have uncontrolled immunosuppression such as AIDS or cancer.
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I have high pressure inside my skull.
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I am willing and able to follow the study's schedule and requirements.
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I have a history of blood clots.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Responder rate

Side effects data

From 2020 Phase 4 trial • 75 Patients • NCT03156504
1%
Lightheadedness with low blood pressure
1%
Pump Malfunction
1%
PTSD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ketamine InfusionExperimental Treatment1 Intervention
ketamine infusion at 0.5 mg/kg over one hour two weeks (14 days) prior to their scheduled surgical date
Group II: Standard Of CareActive Control1 Intervention
No use of ketamine pre, intra, or post-operatively
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine Hydrochloride
2018
Completed Phase 4
~1900

Find a Location

Who is running the clinical trial?

IDAHO PANHANDLE HEALTH DISTRICTUNKNOWN
AXIS Spine Center- a division of Northwest Specialty HospitalLead Sponsor
Jessica Jameson, MDPrincipal Investigatordivision of NSWH
~18 spots leftby Dec 2025
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