Lumbar Spinal FusionPhase 4NCT06513208
Ketorolac Effects on Post-operative Pain and Lumbar Fusion
A Phase 4 study testing Ketorolac Tromethamine in people with Lumbar Spinal Fusion, run by University of Maryland St. Joseph Medical Center at 1 site in United States.
Trial summary
A double blind prospective randomized trial of IV ketorolac vs. placebo in management of patients undergoing lumbar one or two level spinal fusions. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spinal Fusion
- What is being tested?
- Ketorolac Tromethamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 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
Show all 9Show fewer
- Active narcotic use within 3 months of surgery date
- Infection at operative levels
- Any allergies to NSAIDs or Opioids
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland St. Joseph Medical Center
Towson, Maryland, 21204
Sam Rudow, 410-427-5459, samuel.rudow@umm.edu
Justin Tortolani, MD
About this study
Official title: Ketorolac Effects on Post-operative Pain and Lumbar Fusion: a Double Blind Randomized Controlled Trial
A double blind prospective randomized trial of IV ketorolac vs. placebo in management of patients undergoing lumbar one or two level spinal fusions.
- Conditions
- Lumbar Spinal Fusion
- Being tested
- Ketorolac Tromethamine, Placebo
- Keywords
- ketorolac, toradol, lumbar spine fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac TromethamineDrug
IV Ketorolac 15mg every 6 hours, x 4 doses
PlaceboDrug
IV saline as placebo
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac arm | Active comparator | Not described Receives: Drug: Ketorolac Tromethamine |
| Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ketorolac results in decreased post-op opioid use when administered in the first 48 hours (measured by calculating the total amount of MME utilized during the patient's inpatient stay and comparing the control and experimental groups).
Measured: 12 months
Secondary outcomes (2)
Ketorolac use does not decrease spinal fusion rates in one or two level fusion (failure defined as by > than 2 degrees motion on standardized flexion/extension x-rays compared to pre-op imaging analyzed by SpineCAMP software at 6 and 12 months post-op).
Measured: 12 months
Ketorolac use decreases average length of hospital stay (length of stay for both the control group and the experimental group will be counted, and a statistical average for each group will be calculated and compared).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study startJan 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland St. Joseph Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Metrics Diagnostics, Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513208
- Sponsor's protocol ID
- HP-00109853
- Status last verified
- Dec 2025
- First submitted
- 25 Jun 2024
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketorolac Effects on Post-operative Pain and Lumbar Fusion: a Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06513208
- Acronym / sponsor ID
- HP-00109853
- Conditions
- Lumbar Spinal Fusion
- Keywords
- ketorolac, toradol, lumbar spine fusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Maryland St. Joseph Medical CenterUniversity, hospital or other
- Collaborators
- Medical Metrics Diagnostics, Inc
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double blind prospective randomized trial of IV ketorolac vs. placebo in management of patients undergoing lumbar one or two level spinal fusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac arm | Active comparator | Drug: Ketorolac Tromethamine |
| Placebo Arm | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac TromethamineIV Ketorolac 15mg every 6 hours, x 4 doses | Drug | Ketorolac arm |
| PlaceboIV saline as placebo | Drug | Placebo Arm |
Primary outcome
Ketorolac results in decreased post-op opioid use when administered in the first 48 hours (measured by calculating the total amount of MME utilized during the patient's inpatient stay and comparing the control and experimental groups).
Time frame: 12 months
2 secondary outcomes
Ketorolac use does not decrease spinal fusion rates in one or two level fusion (failure defined as by > than 2 degrees motion on standardized flexion/extension x-rays compared to pre-op imaging analyzed by SpineCAMP software at 6 and 12 months post-op).
Time frame: 12 months
Ketorolac use decreases average length of hospital stay (length of stay for both the control group and the experimental group will be counted, and a statistical average for each group will be calculated and compared).
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac Tromethamine in people with Lumbar Spinal Fusion, run by University of Maryland St. Joseph Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aja Janyavula (410-427-5459, ajanyavula@umm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ketorolac results in decreased post-op opioid use when administered in the first 48 hours (measured by calculating the total amount of MME utilized during the patient's inpatient stay and comparing the control and experimental groups). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.