Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE4
428 participants
INTERVENTIONAL
2024-06-28
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1: NSAID Group
Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery
Naproxen 500 Mg
participants will receive Naproxen (500 mg) to take for 7 days after surgery as needed
Ketorolac
participants will receive Ketorolac (15 mg) immediately after surgery
OxyCODONE 5 mg Oral Tablet
participants will receive OxyCODONE (5 mg) to take for 7 days after surgery as needed
Metaxalone 800 MG
participants will receive Metaxalone (800 MG) to take for 7 days after surgery as needed
Group 2: Control Group
Participants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion surgery
OxyCODONE 5 mg Oral Tablet
participants will receive OxyCODONE (5 mg) to take for 7 days after surgery as needed
Metaxalone 800 MG
participants will receive Metaxalone (800 MG) to take for 7 days after surgery as needed
Interventions
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Naproxen 500 Mg
participants will receive Naproxen (500 mg) to take for 7 days after surgery as needed
Ketorolac
participants will receive Ketorolac (15 mg) immediately after surgery
OxyCODONE 5 mg Oral Tablet
participants will receive OxyCODONE (5 mg) to take for 7 days after surgery as needed
Metaxalone 800 MG
participants will receive Metaxalone (800 MG) to take for 7 days after surgery as needed
Eligibility Criteria
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Inclusion Criteria
* Capacity to enroll
* English speaking
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Rothman Institute Orthopaedics
OTHER
Responsible Party
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Locations
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Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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CKEP2024.0800
Identifier Type: -
Identifier Source: org_study_id
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