Spine FusionPhase 4NCT06484192
Pain Control After Lumbar Spine Fusion
A Phase 4 study testing Naproxen 500 Mg, Ketorolac and OxyCODONE 5 mg Oral Tablet in people with Spine Fusion and NSAID (Non-Steroidal Anti-Inflammatory Drug), run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The purpose of this randomized controlled trial is to determine if patients who receive non-steroidal anti-inflammatory medications (NSAIDs) following elective lumbar spinal fusion have increased rates of symptomatic nonunion requiring revision spinal surgery at two-years follow-up, compared to those who do not… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spine Fusion, NSAID (Non-Steroidal Anti-Inflammatory Drug), Postoperative Pain
- What is being tested?
- Naproxen 500 Mg, Ketorolac and OxyCODONE 5 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2024to 30 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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)
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- Connective tissue disease
- Operative indication due to infection, neoplasm, or trauma
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
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
The purpose of this randomized controlled trial is to determine if patients who receive non-steroidal anti-inflammatory medications (NSAIDs) following elective lumbar spinal fusion have increased rates of symptomatic nonunion requiring revision spinal surgery at two-years follow-up, compared to those who do not receive NSAIDs.
- Being tested
- Naproxen 500 Mg, Ketorolac, OxyCODONE 5 mg Oral Tablet, Metaxalone 800 MG
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen 500 MgDrug
participants will receive Naproxen (500 mg) to take for 7 days after surgery as needed
KetorolacDrug
participants will receive Ketorolac (15 mg) immediately after surgery
OxyCODONE 5 mg Oral TabletDrug
participants will receive OxyCODONE (5 mg) to take for 7 days after surgery as needed
Metaxalone 800 MGDrug
participants will receive Metaxalone (800 MG) to take for 7 days after surgery as needed
| Study group | Role | What they receive |
|---|---|---|
| Group 1: NSAID Group | Active comparator | Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery Receives: Drug: Naproxen 500 Mg; Drug: Ketorolac; Drug: OxyCODONE 5 mg Oral Tablet; Drug: Metaxalone 800 MG |
| Group 2: Control Group | Active comparator | Participants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion surgery Receives: Drug: OxyCODONE 5 mg Oral Tablet; Drug: Metaxalone 800 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion failure
Failure of fusion surgery will be measured by the rate of revisions as demonstrated by participant x-rays
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start28 Jun 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine 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
- Single blind
- Who is masked
- Investigator
- 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
- NCT06484192
- Sponsor's protocol ID
- CKEP2024.0800
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- 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 3 Jul 2024. 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
- NCT06484192
- Acronym / sponsor ID
- CKEP2024.0800
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 28 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 3 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.
The purpose of this randomized controlled trial is to determine if patients who receive non-steroidal anti-inflammatory medications (NSAIDs) following elective lumbar spinal fusion have increased rates of symptomatic nonunion requiring revision spinal surgery at two-years follow-up, compared to those who do not receive NSAIDs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: NSAID Group | Active comparator | Drug: Naproxen 500 Mg, Drug: Ketorolac, Drug: OxyCODONE 5 mg Oral Tablet, Drug: Metaxalone 800 MGParticipants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery |
| Group 2: Control Group | Active comparator | Drug: OxyCODONE 5 mg Oral Tablet, Drug: Metaxalone 800 MGParticipants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion surgery |
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 |
|---|---|---|
| Naproxen 500 Mgparticipants will receive Naproxen (500 mg) to take for 7 days after surgery as needed | Drug | Group 1: NSAID Group |
| Ketorolacparticipants will receive Ketorolac (15 mg) immediately after surgery | Drug | Group 1: NSAID Group |
| OxyCODONE 5 mg Oral Tabletparticipants will receive OxyCODONE (5 mg) to take for 7 days after surgery as needed | Drug | Group 1: NSAID Group, Group 2: Control Group |
| Metaxalone 800 MGparticipants will receive Metaxalone (800 MG) to take for 7 days after surgery as needed | Drug | Group 1: NSAID Group, Group 2: Control Group |
Primary outcome
Fusion failure
Time frame: 2 years
Failure of fusion surgery will be measured by the rate of revisions as demonstrated by participant x-rays
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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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. This study is not recruiting at the moment.
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 4 study testing Naproxen 500 Mg, Ketorolac and OxyCODONE 5 mg Oral Tablet in people with Spine Fusion and NSAID (Non-Steroidal Anti-Inflammatory Drug), 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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 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?
Results are not available in the source record.
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?
Fusion failure (time frame: 2 years). 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 3 Jul 2024.