What this study is
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.
What's being tested
- Ketorolac
Intervention · DRUG
Intravenous ketorolac 15 mg administered every 6 hours for up to 48 hours after surgery.
- Naproxen
Intervention · DRUG
Oral naproxen 500 mg administered twice daily for 7 days after hospital discharge.
- Standard Postoperative Pain Management
Intervention · OTHER
Standard postoperative multimodal pain regimen used at the institution, excluding NSAIDs administered as part of the study intervention.
Study details
- Official title
- Randomized Controlled Trial of Postoperative Inpatient Ketorolac and Outpatient Naproxen Use Following Elective Lumbar Spine Fusion
- Sponsor
- Rothman Institute Orthopaedics
- Conditions
- NSAID (Non-Steroidal Anti-Inflammatory Drug) · Lumbar Spine Fusion · Ketorolac · Postoperative Pain
- Enrolling
- 428 people
- Starts
- 2024-07-08
- Est. completion
- 2028-12-31
- Design
- Single-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- ≥18 years of age, ≥1-level planned lumbar spinal fusion
- Capacity to enroll
- English speaking
You can't join if
- 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)
- Connective tissue disease
- Operative indication due to infection, neoplasm, or trauma
- Currently pregnant
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openRothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States
Study team
Sponsor
Rothman Institute Orthopaedics
Study ID CKEP-iRISID2024-0800
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.