NSAID (Non-Steroidal Anti-Inflammatory Drug)Phase 3NCT07743606
NSAIDS Following Elective Lumbar Spine Fusion
A Phase 3 study testing Ketorolac, Naproxen and Standard Postoperative Pain Management in people with NSAID (Non-Steroidal Anti-Inflammatory Drug) and Lumbar Spine Fusion, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
This study will compare two common approaches to pain control after lumbar spinal fusion surgery. Participants will be randomly assigned to receive either standard pain medication alone or standard pain medication plus a short course of nonsteroidal anti-inflammatory drugs (NSAIDs), including intravenous ketorolac… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- NSAID (Non-Steroidal Anti-Inflammatory Drug), Lumbar Spine Fusion, Ketorolac
- What is being tested?
- Ketorolac, Naproxen and Standard Postoperative Pain Management
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2024to 31 Dec 2028
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years of age, ≥1-level planned lumbar spinal fusion
- Capacity to enroll
- English speaking
Who cannot join
- Chronic kidney disease (preoperative creatinine ≥1.4)
- History of gastrointestinal bleed or peptic ulcer disease
- History of spinal fusion nonunion
- Non-steroidal anti-inflammatory drug allergy
- Previously diagnosed coagulopathy
- Preoperative thrombocytopenia (platelets <100,000)
Show all 9Show fewer
- Connective tissue disease
- Operative indication due to infection, neoplasm, or trauma
- Currently pregnant
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
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Randomized Controlled Trial of Postoperative Inpatient Ketorolac and Outpatient Naproxen Use Following Elective Lumbar Spine Fusion
This study will compare two common approaches to pain control after lumbar spinal fusion surgery. Participants will be randomly assigned to receive either standard pain medication alone or standard pain medication plus a short course of nonsteroidal anti-inflammatory drugs (NSAIDs), including intravenous ketorolac while in the hospital and oral naproxen for one week after discharge.
The main goal is to determine whether taking NSAIDs after surgery affects how well the spine heals by increasing the chance of needing another surgery because the bones did not fuse properly within 2 years. The study will also evaluate pain medication use, recovery, hospital readmissions, complications, physical therapy progress, patient-reported pain and function, and overall healing. The results will help determine whether NSAIDs can be used safely as part of pain management after lumbar spinal fusion surgery while potentially reducing the need for opioid medications.
- Conditions
- NSAID (Non-Steroidal Anti-Inflammatory Drug), Lumbar Spine Fusion, Ketorolac, Postoperative Pain
- Being tested
- Ketorolac, Naproxen, Standard Postoperative Pain Management
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Intravenous ketorolac 15 mg administered every 6 hours for up to 48 hours after surgery.
NaproxenDrug
Oral naproxen 500 mg administered twice daily for 7 days after hospital discharge.
Standard Postoperative Pain ManagementOther
Standard postoperative multimodal pain regimen used at the institution, excluding NSAIDs administered as part of the study intervention.
| Study group | Role | What they receive |
|---|---|---|
| NSAID Group | Active comparator | Participants will receive the institution's standard postoperative pain management regimen plus postoperative NSAID therapy consisting of intravenous ketorolac (15 mg every 6 hours for up to 48 hours while hospitalized) followed by oral naproxen (500 mg twice daily for 7 days after hospital discharge). If a participant is discharged before completing 48 hours of ketorolac therapy, no additional inpatient doses will be administered. Receives: Drug: Ketorolac; Drug: Naproxen; Other: Standard Postoperative Pain Management |
| Control Group | Active comparator | Participants will receive the institution's standard postoperative pain management regimen without postoperative NSAIDs. No placebo will be administered. Receives: Other: Standard Postoperative Pain Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision surgery for symptomatic lumbar spinal fusion nonunion
The proportion of participants who undergo revision lumbar fusion surgery for symptomatic nonunion (pseudarthrosis), as determined by the treating spine surgeon based on clinical evaluation and imaging findings.
Measured: Up to 2 years after surgery
Secondary outcomes (3)
Radiographic lumbar fusion status
The proportion of participants with radiographic evidence of nonunion (pseudarthrosis) based on standard radiographs and/or computed tomography (CT), as determined by the treating spine surgeon.
Measured: 6 months, 1 year, and 2 years after surgery
Inpatient opioid consumption
Total opioid consumption during hospitalization, converted to morphine milligram equivalents (MME).
Measured: During the index hospitalization (up to approximately 3 days)
Postoperative outpatient opioid consumption
Daily opioid use, reported as morphine milligram equivalents (MME), at routine postoperative follow-up visits.
Measured: 2 weeks, 6 weeks, 6 months, 1 year, and 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start8 Jul 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSAID (Non-Steroidal Anti-Inflammatory Drug)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743606
- Sponsor's protocol ID
- CKEP-iRISID2024-0800
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Postoperative Inpatient Ketorolac and Outpatient Naproxen Use Following Elective Lumbar Spine Fusion
- ClinicalTrials.gov ID
- NCT07743606
- Acronym / sponsor ID
- CKEP-iRISID2024-0800
- Conditions
- NSAID (Non-Steroidal Anti-Inflammatory Drug), Lumbar Spine Fusion, Ketorolac, Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Aug 2026 (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.
This study will compare two common approaches to pain control after lumbar spinal fusion surgery. Participants will be randomly assigned to receive either standard pain medication alone or standard pain medication plus a short course of nonsteroidal anti-inflammatory drugs (NSAIDs), including intravenous ketorolac while in the hospital and oral naproxen for one week after discharge.
The main goal is to determine whether taking NSAIDs after surgery affects how well the spine heals by increasing the chance of needing another surgery because the bones did not fuse properly within 2 years. The study will also evaluate pain medication use, recovery, hospital readmissions, complications, physical therapy progress, patient-reported pain and function, and overall healing. The results will help determine whether NSAIDs can be used safely as part of pain management after lumbar spinal fusion surgery while potentially reducing the need for opioid medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSAID Group | Active comparator | Drug: Ketorolac, Drug: Naproxen, Other: Standard Postoperative Pain ManagementParticipants will receive the institution's standard postoperative pain management regimen plus postoperative NSAID therapy consisting of intravenous ketorolac (15 mg every 6 hours for up to 48 hours while hospitalized) followed by oral naproxen (500 mg twice daily for 7 days after hospital discharge). If a participant is discharged before completing 48 hours of ketorolac therapy, no additional inpatient doses will be administered. |
| Control Group | Active comparator | Other: Standard Postoperative Pain ManagementParticipants will receive the institution's standard postoperative pain management regimen without postoperative NSAIDs. No placebo will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years of age, ≥1-level planned lumbar spinal fusion
- Capacity to enroll
- English speaking
Key exclusion criteria (9 listed)
- Chronic kidney disease (preoperative creatinine ≥1.4)
- History of gastrointestinal bleed or peptic ulcer disease
- History of spinal fusion nonunion
- Non-steroidal anti-inflammatory drug allergy
- Previously diagnosed coagulopathy
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 |
|---|---|---|
| KetorolacIntravenous ketorolac 15 mg administered every 6 hours for up to 48 hours after surgery. | Drug | NSAID Group |
| NaproxenOral naproxen 500 mg administered twice daily for 7 days after hospital discharge. | Drug | NSAID Group |
| Standard Postoperative Pain ManagementStandard postoperative multimodal pain regimen used at the institution, excluding NSAIDs administered as part of the study intervention. | Other | Control Group, NSAID Group |
Primary outcome
Revision surgery for symptomatic lumbar spinal fusion nonunion
Time frame: Up to 2 years after surgery
The proportion of participants who undergo revision lumbar fusion surgery for symptomatic nonunion (pseudarthrosis), as determined by the treating spine surgeon based on clinical evaluation and imaging findings.
3 secondary outcomes
Radiographic lumbar fusion status
Time frame: 6 months, 1 year, and 2 years after surgery
Inpatient opioid consumption
Time frame: During the index hospitalization (up to approximately 3 days)
Postoperative outpatient opioid consumption
Time frame: 2 weeks, 6 weeks, 6 months, 1 year, and 2 years after surgery
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 4 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketorolac, Naproxen and Standard Postoperative Pain Management in people with NSAID (Non-Steroidal Anti-Inflammatory Drug) and Lumbar Spine Fusion, run by Rothman Institute Orthopaedics 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 3 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: enrolling by invitation, as of the sponsor's last update on 4 Aug 2026. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revision surgery for symptomatic lumbar spinal fusion nonunion (time frame: Up to 2 years after surgery). 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 4 Aug 2026.