RECRUITING

Ketorolac on Posterior Thoracolumbar Spinal Fusions

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Conditions

Thoracolumbar Spinal Fusions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-10-03
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03278691

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Over 18 years of age
  2. * Elective thoracolumbar posterior lumbar instrumented interbody fusion
  3. * Minimally invasive spine surgery (MIS)
  4. * 3 or fewer levels
  5. * Bone Morphogenetic Protein (BMP) use in interbody fusion (1.05mg/level or less)
  6. * Consent to study participation
  1. * Active tobacco smoker or history of tobacco smoking in the past 6 weeks
  2. * Previous history of surgery at operative level(s)
  3. * History of chronic inflammatory/rheumatological condition
  4. * History of systemic steroid use in the past 3 months
  5. * Auto/Workers' compensation patients
  6. * Traumatic pathology at the operative levels
  7. * Infection at the operative levels
  8. * Tumor at the operative levels
  9. * Major psychiatric illness as diagnosed by psychiatrists and on major anti- psychotic/depressants
  10. * Patients on chemotherapeutic agents in the last 6 months
  11. * Patients who has a history of allergy to Ketorolac
  12. * Patients with a history of chemical addiction requiring professional rehabilitation and/or assistance
  13. * Patients with current creatinine \> 1.5mg/dl
  14. * Patients with history of coagulopathy
  15. * Patients with history of hepatic impairment
  16. * Patients with uncontrolled cardiovascular disease

Contacts and Locations

Study Contact

Doris Tong, MD
CONTACT
(248) 763-2380
doris.tong@michiganspineandbrainsurgeons.com
Chad Claus, DO
CONTACT

Principal Investigator

Doris Tong, MD
STUDY_DIRECTOR
Michigan Spine and Brain Surgeons

Study Locations (Sites)

Providence-Providence Park, Southfield
Southfield, Michigan, 48075
United States

Collaborators and Investigators

Sponsor: Ascension South East Michigan

  • Doris Tong, MD, STUDY_DIRECTOR, Michigan Spine and Brain Surgeons

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-10-03
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2017-10-03
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Thoracolumbar Spinal Fusions