A Phase 3 interventional study of Ketorolac and Naproxen in NSAID (Non-Steroidal Anti-Inflammatory Drug), Lumbar Spine Fusion and Ketorolac, sponsored by Rothman Institute Orthopaedics. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Rothman Institute Orthopaedics · Phase 3, Interventional, and Treatment
Among 68 studies testing ketorolac in Pain, Postoperative — 9 open to participants now, 9 under way, 3 of them phase 3. Ketorolac · Pain, Postoperative.
Among the 68 studies testing ketorolac in Pain, Postoperative, this one has the largest planned enrollment, is one of 3 that started in 2024, is one of 14 in phase 3, and was the 67th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 428 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →9 of the 68 studies testing ketorolac in Pain, Postoperative are open now, in 2 countries. Each count lists the studies.
Ketorolac: first FDA approval 1989 (TORADOL), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →68 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 3 started in 2024.
Median enrollment 77 across the 68 interventional studies. Of the 47 that completed or were terminated, 20 (43%) have results posted.
5 of 68 have an industry lead sponsor. The 10 most frequent:
Rothman Institute Orthopaedics is the lead sponsor of 119 studies on the registry; 18 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
21 studies in Pain, Postoperative by Rothman Institute Orthopaedics: 9 open now, 9 under way, 3 of them phase 3. Of 1 finished, 0 (0%) have results posted.
Among the 21 studies in Pain, Postoperative by Rothman Institute Orthopaedics, this one has the largest planned enrollment of the 20 interventional ones, is one of 4 that started in 2024, is one of 8 in phase 3, and was the 21st registered.
Rothman Institute Orthopaedics’s Pain, Postoperative studies by the year they started, since 2017.
6 of the studies testing ketorolac in Pain, Postoperative that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03823534Phase 3St. Louis UniversityPost-Op Pain Control for Prophylactic Intramedullary Nailing. | 2026-12-31 |
| NCT07047040Phase 3Assiut UniversityAnalgesic Efficacy of Pre-operative Dose of Ketorolac and Gabapentin | 2027-10-30 |
| NCT06158620University of Texas Southwestern Medical CenterIntra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease | 2027-04-01 |
| NCT05543785Mansoura UniversityKetorolac Intravenous Regional Analgesia in Lower Limb Surgeries | 2027-05-30 |
| NCT07840183Northwestern UniversityEpidural Analgesia Versus Opioid-sparing Analgesia for Open Ventral Hernia Repair With Transversus Abdominis Release | 2027-09 |
Among the 68 studies testing ketorolac in Pain, Postoperative, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Rothman Institute Orthopaedics’s 21 in Pain, Postoperative:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Ketorolac · Drug: Naproxen · Other: Standard Postoperative Pain Management
Participants will receive the institution's standard postoperative pain management regimen without postoperative NSAIDs. No placebo will be administered.
Other: Standard Postoperative Pain Management
Intravenous ketorolac 15 mg administered every 6 hours for up to 48 hours after surgery.
Oral naproxen 500 mg administered twice daily for 7 days after hospital discharge.
Standard postoperative multimodal pain regimen used at the institution, excluding NSAIDs administered as part of the study intervention.
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.
Time frame: Up to 2 years after surgery
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.
Time frame: 6 months, 1 year, and 2 years after surgery
Inpatient opioid consumption
Total opioid consumption during hospitalization, converted to morphine milligram equivalents (MME).
Time frame: 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.
Time frame: 2 weeks, 6 weeks, 6 months, 1 year, and 2 years after surgery
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drugs tested here: Ketorolac · Naproxen
Rothman Institute Orthopaedics →