IV ketorolac for pain after one- or two-level lumbar fusion
Official title: Ketorolac Effects on Post-operative Pain and Lumbar Fusion: a Double Blind Randomized Controlled Trial
Run by University of Maryland St. Joseph Medical Center · NCT06513208 · Data updated 2026-11-12
This study will test whether an IV ketorolac dose after surgery reduces post-operative pain and opioid use for adults having elective one- or two-level posterior lumbar fusion.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | University of Maryland St. Joseph Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Towson, Maryland) |
| Status | Recruiting |
| Started | January 2026 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | December 22, 2025 |
| Trial ID | NCT06513208 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–85 scheduled for elective one- or two-level posterior instrumented lumbar fusion who can consent, speak English, and have no renal failure, recent smoking or chronic opioid use, revision surgery, active cancer treatment, or NSAID/opioid allergies are ideal candidates.
✕Probably not a fit
Patients with renal impairment, active or recent smokers, recent or ongoing narcotic use, revision fusion cases, active cancer or recent chemotherapy, or allergies to NSAIDs/opioids are unlikely to be eligible or to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled Phase 4 trial comparing IV ketorolac to placebo in adults undergoing elective one- or two-level posterior instrumented lumbar fusion. Participants aged 18–85 who meet medical criteria will be randomized to receive ketorolac or placebo around the time of surgery and followed through post-operative visits. Pain scores and analgesic (opioid) use will be tracked, and safety measures such as renal function and bleeding will be monitored. Common exclusion criteria include significant renal impairment, recent smoking, revision surgery, active cancer or recent chemotherapy, recent narcotic use, and allergies to NSAIDs or opioids.
Why it matters
Potential benefit: If successful, patients may have better post-operative pain control and require fewer opioid pain medicines after lumbar fusion.
How similar studies have gone: NSAIDs including ketorolac have been shown to reduce post-operative pain and opioid use in many surgeries, but data specific to lumbar fusion and effects on fusion rates are mixed and not fully settled.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-85 years old (inclusive) * Elective posterior lumbar instrumented fusion * One or two level fusion * Consent to participate in study and willing to adhere to study follow up * English proficiency Exclusion Criteria: * \< 18 or \> 85 years old * History of renal failure, dialysis, or creatinine over 1.50 mg/dl * Active or recent smoker (active within past 6 months) * Revision surgery * Auto/worker compensation * Active cancer or history of chemotherapy in past 6 months * Active narcotic use within 3 months of surgery date * Infection at operative levels * Any allergies to NSAIDs or Opioids
Where it's running
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University of Maryland St. Joseph Medical Center
Towson, Maryland, United States Recruiting
Study contacts
- Study coordinator: Aja Janyavula
- Email: ajanyavula@umm.edu
- Phone: 410-427-5459
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.