← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

KIPSs Trial 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.Check my eligibility

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.See study design

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.

KIPSs Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a repeat surgery on my neck or lower back.

Select...

I have had neck or back pain for more than 12 weeks.

Select...

I have been using daily pain medication equivalent to 50 or more morphine units for over 6 weeks.

KIPSs Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Degree of reduction in opiate consumption following surgery

Secondary outcome measures

Responder rate

Side effects data

From 2020 Phase 4 trial • 75 Patients • NCT03156504

Lightheadedness with low blood pressure

Pump Malfunction

PTSD

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine

KIPSs 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

~1000

0 / 3Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what kind of individuals is this trial appropriate?

"In order to qualify for the trial, applicants must have already undergone spinal fusion and be within a certain age range (18-75). 40 participants are being recruited in total."

Answered by AI

Are there any risks associated with Ketamine Infusion treatments?

"Ketamine Infusion scores a 3 on our safety rating scale, confirming that this Phase 4 treatment is approved for use."

Answered by AI

Is there still capacity for patients to join this trial?

"Indeed, the trial is open for enrollment. Clinicaltrials.gov reveals that it was first posted on September 18th 2023 and updated on September 28th of the same year."

Answered by AI

Is this clinical investigation open to individuals aged 50 and up?

"To be eligible for this medical trial, participants must be younger than 75 and have reached the age of majority."

Answered by AI

What is the maximum capacity for participants in this medical research?

"Yes, according to clinicaltrials.gov, this research is currently progressing and has been actively advertising since September 18th of 2023 with the most recent update occurring on September 28th. 40 individuals will be enrolled in total at one trial site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Pre-Operative Ketamine Infusion for Post Operative Pain Control After Revision Spinal Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06066879.

All > Vision > Spokane