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Ketorolac on Posterior Thoracolumbar Spinal Fusions

Ketorolac on Posterior Thoracolumbar Spinal Fusions

Recruiting
18 years and older
All
Phase 4

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Overview

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.

Eligibility

Inclusion Criteria:

  • 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 Criteria:

  • 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 antipsychotic /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

Study details
    Thoracolumbar Spinal Fusions

NCT03278691

Ascension South East Michigan

25 January 2024

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