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Non-steroidal Anti-inflammatory Drug

Pain Medications for Postoperative Pain After Spinal Fusion

Phase 4
Waitlist Available
Research Sponsored by Rothman Institute Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years of age, with ≥1-level planned lumbar spinal fusion
Be older than 18 years old
Must not have
Connective tissue disease
Chronic kidney disease (preoperative creatinine ≥1.4)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial aims to find out if patients who take non-steroidal anti-inflammatory medications (NSAIDs) after back surgery have a higher chance of needing a second surgery due to complications compared to those

Who is the study for?
This trial is for patients who have had elective lumbar spinal fusion surgery and are managing postoperative pain. Participants should not have conditions that prevent the use of NSAIDs, such as kidney failure or a history of stomach ulcers.
What is being tested?
The study is testing if using NSAIDs like Ketorolac, Naproxen, and Metaxalone after spine surgery affects the healing process over two years compared to not using these drugs. It's a randomized controlled trial.
What are the potential side effects?
Possible side effects from NSAIDs may include stomach upset or bleeding, kidney problems, increased blood pressure, and allergic reactions. OxyCODONE can cause drowsiness, constipation, addiction risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and scheduled for a lumbar spinal fusion surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a connective tissue disease.
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My kidney function is reduced with a creatinine level of 1.4 or higher.
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I have had a stomach ulcer or bleeding in my stomach before.
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I have had a spinal fusion that did not heal properly.
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I have been diagnosed with a blood clotting disorder.
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I need surgery because of an infection, tumor, or injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fusion failure

Awards & Highlights

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

Trial Design

2Treatment groups
Active Control
Group I: Group 1: NSAID GroupActive Control4 Interventions
Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery
Group II: Group 2: Control GroupActive Control2 Interventions
Participants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion surgery

Find a Location

Who is running the clinical trial?

Rothman Institute OrthopaedicsLead Sponsor
126 Previous Clinical Trials
22,156 Total Patients Enrolled
~250 spots leftby Jun 2025
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