Pain Control After Lumbar Spine Fusion
Randomized Controlled Trial of Postoperative Inpatient Ketorolac and Outpatient Naproxen Use Following Elective Lumbar Spine Fusion
1 other identifier
interventional
428
1 country
1
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 rates of symptomatic nonunion requiring revision spinal surgery at two-years follow-up, compared to those who do not receive NSAIDs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2024
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2024
CompletedStudy Start
First participant enrolled
June 28, 2024
CompletedFirst Posted
Study publicly available on registry
July 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJuly 3, 2024
June 1, 2024
1 year
June 26, 2024
June 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Fusion failure
Failure of fusion surgery will be measured by the rate of revisions as demonstrated by participant x-rays
2 years
Study Arms (2)
Group 1: NSAID Group
ACTIVE COMPARATORParticipants 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 COMPARATORParticipants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion surgery
Interventions
participants will receive Naproxen (500 mg) to take for 7 days after surgery as needed
participants will receive Ketorolac (15 mg) immediately after surgery
participants will receive OxyCODONE (5 mg) to take for 7 days after surgery as needed
participants will receive Metaxalone (800 MG) to take for 7 days after surgery as needed
Eligibility Criteria
You may qualify if:
- ≥18 years of age, ≥1-level planned lumbar spinal fusion
- Capacity to enroll
- English speaking
You may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2024
First Posted
July 3, 2024
Study Start
June 28, 2024
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
July 3, 2024
Record last verified: 2024-06