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Nonsteroidal Anti-inflammatory Drug

Ketorolac for Post-Surgical Pain in Thoracolumbar Fusion

Phase 4
Recruiting
Led By Chad Claus, DO
Research Sponsored by Ascension South East Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Use of Bone Morphogenetic Protein (BMP) in interbody fusion (1.05mg/level or less)
Over 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months and/or 24 months postoperatively
Awards & highlights

Study Summary

This trial is testing whether using a painkiller called ketorolac early after spinal surgery helps with pain without affecting the success of the surgery.

Who is the study for?
This trial is for adults over 18 who need a specific back surgery (thoracolumbar posterior lumbar instrumented interbody fusion) using minimally invasive techniques and a certain bone protein. Smokers, those with recent surgeries at the same spot, chronic inflammatory conditions, steroid use in past 3 months, or major psychiatric illnesses can't join.Check my eligibility
What is being tested?
The study tests if low-dose ketorolac given within the first 48 hours after spine surgery provides good pain relief without affecting long-term success of spinal fusions compared to standard painkillers that don't include NSAIDs like ketorolac.See study design
What are the potential side effects?
Ketorolac may cause side effects such as stomach issues, bleeding problems, kidney damage in people with existing issues, and possibly affect how well the spine heals after surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am using BMP for spinal fusion at a dose of 1.05mg per level or less.
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I am over 18 years old.
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I am scheduled for a specific spine surgery involving metal implants and bone graft.
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I am scheduled for a minimally invasive spine surgery.
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My surgery will involve 3 or fewer specific areas.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months and/or 24 months postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months and/or 24 months postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fusion Construct X-Ray
Secondary outcome measures
Complications/Adverse events
Length of Stay (LOS)
Morphine equivalent doses
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Ketorolac 15 mg (15mg/ml) IV Q6H
Group II: PlaceboPlacebo Group1 Intervention
Drug: Placebo Saline 1 ml IV Q6H
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketorolac
2014
Completed Phase 4
~1760

Find a Location

Who is running the clinical trial?

Ascension South East MichiganLead Sponsor
18 Previous Clinical Trials
31,924 Total Patients Enrolled
Chad Claus, DOPrincipal InvestigatorProvidence-Providence Park Hospital
Doris Tong, MDStudy DirectorMichigan Spine and Brain Surgeons

Media Library

Ketorolac (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT03278691 — Phase 4
Thoracolumbar Fusion Research Study Groups: Placebo, Intervention
Thoracolumbar Fusion Clinical Trial 2023: Ketorolac Highlights & Side Effects. Trial Name: NCT03278691 — Phase 4
Ketorolac (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03278691 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
BMJ OpenJournal
The Effect of Ketorolac on Posterior Thoracolumbar Spinal Fusions: A Prospective Double-blinded Randomised Placebo-controlled Trial Protocol
Claus, Chad F, Evan Lytle, Doris Tong, Diana Sigler, Dominick Lago, Matthew Bahoura, Amarpal Dosanjh, et al.. 2019. “The Effect of Ketorolac on Posterior Thoracolumbar Spinal Fusions: A Prospective Double-blinded Randomised Placebo-controlled Trial Protocol”. BMJ Open. BMJ. doi:10.1136/bmjopen-2018-025855.
clinicaltrials.govStudy
Ketorolac on Posterior Thoracolumbar Spinal Fusions
2017. "Ketorolac on Posterior Thoracolumbar Spinal Fusions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03278691.
~80 spots leftby Apr 2025
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