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Ketorolac on Posterior Thoracolumbar Spinal Fusions | Clinical Trials | Clareo Health

UNKNOWNPHASE4

Ketorolac on Posterior Thoracolumbar Spinal Fusions

The Effect of Ketorolac on Posterior Thoracolumbar Spinal Fusions: a Prospective Randomized Controlled Trial

NCT03278691•Henry Ford Health System

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-operative analgesia without the use of NSAIDs.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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 anti- psychotic/depressants
•Patients on chemotherapeutic agents in the last 6 months
+6 more criteria

Locations (1)

Providence-Providence Park, Southfield

Southfield, Michigan, United States

Key Dates

Start Date

October 3, 2017

Primary Completion Date

December 31, 2023

Completion Date

December 31, 2025

Last Updated

April 20, 2023

Enrollment

600

ESTIMATED participants

Conditions

Thoracolumbar Spinal Fusions

Interventions

Saline

DRUG

Ketorolac

DRUG

Contacts

Doris Tong, MD

CONTACT

(248) 763-2380 doris.tong@michiganspineandbrainsurgeons.com

Chad Claus, DO

CONTACT