Status:
UNKNOWN
Ketorolac on Posterior Thoracolumbar Spinal Fusions
Lead Sponsor:
Henry Ford Health System
Conditions:
Thoracolumbar Spinal Fusions
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To determine is low-dose ketorolac use in the early post-operative period (within 48 hours) provides adequate analgesia without long term adverse effect on spinal fusion rates when compared to post-op...
Eligibility Criteria
Inclusion
- Over 18 years of age
- Elective thoracolumbar posterior lumbar instrumented interbody fusion
- Minimally invasive spine surgery (MIS)
- 3 or fewer levels
- Bone Morphogenetic Protein (BMP) use in interbody fusion (1.05mg/level or less)
- Consent to study participation
Exclusion
- Active tobacco smoker or history of tobacco smoking in the past 6 weeks
- Previous history of surgery at operative level(s)
- History of chronic inflammatory/rheumatological condition
- History of systemic steroid use in the past 3 months
- Auto/Workers' compensation patients
- Traumatic pathology at the operative levels
- Infection at the operative levels
- Tumor at the operative levels
- Major psychiatric illness as diagnosed by psychiatrists and on major anti- psychotic/depressants
- Patients on chemotherapeutic agents in the last 6 months
- Patients who has a history of allergy to Ketorolac
- Patients with a history of chemical addiction requiring professional rehabilitation and/or assistance
- Patients with current creatinine \> 1.5mg/dl
- Patients with history of coagulopathy
- Patients with history of hepatic impairment
- Patients with uncontrolled cardiovascular disease
Key Trial Info
Start Date :
October 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03278691
Start Date
October 3 2017
End Date
December 31 2025
Last Update
April 20 2023
Active Locations (1)
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1
Providence-Providence Park, Southfield
Southfield, Michigan, United States, 48075