Status:
ENROLLING_BY_INVITATION
Pain Control After Lumbar Spine Fusion
Lead Sponsor:
Rothman Institute Orthopaedics
Conditions:
Spine Fusion
NSAID (Non-Steroidal Anti-Inflammatory Drug)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 rate...
Eligibility Criteria
Inclusion
- ≥18 years of age, ≥1-level planned lumbar spinal fusion
- Capacity to enroll
- English speaking
Exclusion
- 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
Key Trial Info
Start Date :
June 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
428 Patients enrolled
Trial Details
Trial ID
NCT06484192
Start Date
June 28 2024
End Date
June 30 2025
Last Update
July 3 2024
Active Locations (1)
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1
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107