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-operative analgesia without the use of NSAIDs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
600
Providence-Providence Park, Southfield
Southfield, Michigan, United States
RECRUITINGFusion Construct X-Ray
Each fusion level will be evaluated individually and as part of the complete fusion construct. Fusion will be evaluated by blinded independent neuroradiologists using XR.
Time frame: 6 months postoperatively
Fusion Construct X-Ray
Each fusion level will be evaluated individually and as part of the complete fusion construct. Fusion will be evaluated by blinded independent neuroradiologists using XR.
Time frame: 12 months postoperatively
Fusion Construct X-Ray
Each fusion level will be evaluated individually and as part of the complete fusion construct. Fusion will be evaluated by blinded independent neuroradiologists using XR.
Time frame: 24 months postoperatively
Visual Analogue Scale (VAS) for pain
* Patient will be given the VAS on the source document in order to draw on the scale * Blinded investigators
Time frame: Every 8 hours x 48 hours postoperatively
Length of Stay (LOS)
-Measured in days (24 hours) • Automatic data capture on discharge by the hospital EMR
Time frame: 12 months postoperatively
Morphine equivalent doses
-Non-study narcotics taken by patients on the floor are converted to morphine equivalent doses * Morphine equivalent doses are compared between the two groups daily for the first 48h * Data extracted from hospital EMR on discharge
Time frame: 12 months postoperatively
Complications/Adverse events
Chad Claus, DO
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
-Ketorolac-related short term in-hospital complications: GI ulceration and bleeding, GI perforation, PO bleeding, acute renal failure, anaphylactic/anaphylactoid reactions, liver failure * Collected by investigators daily during round * Document on the source document
Time frame: 12 months postoperatively
Quality of life - long term
Oswestry Disability Index (ODI) * We will administer validated scales (ODI) * Face-to -face interview during clinic visit
Time frame: 12 months and/or 24 months postoperatively