IV ketorolac for pain after one- or two-level lumbar fusion
Ketorolac Effects on Post-operative Pain and Lumbar Fusion: a Double Blind Randomized Controlled Trial
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 |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Maryland St. Joseph Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Towson, Maryland) |
| Trial ID | NCT06513208 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Towson, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.