<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03278691</url>
  </required_header>
  <id_info>
    <org_study_id>IRB # 1072359</org_study_id>
    <nct_id>NCT03278691</nct_id>
  </id_info>
  <brief_title>Ketorolac on Posterior Thoracolumbar Spinal Fusions</brief_title>
  <official_title>The Effect of Ketorolac on Posterior Thoracolumbar Spinal Fusions: a Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ascension South East Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ascension South East Michigan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine is low-dose ketorolac use in the early post-operative period (within 48 hours)&#xD;
      provides adequate analgesia without long term adverse effect on spinal fusion rates when&#xD;
      compared to post-operative analgesia without the use of NSAIDs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fusion Construct X-Ray</measure>
    <time_frame>6 months postoperatively</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fusion Construct X-Ray</measure>
    <time_frame>12 months postoperatively</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fusion Construct X-Ray</measure>
    <time_frame>24 months postoperatively</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS) for pain</measure>
    <time_frame>Every 8 hours x 48 hours postoperatively</time_frame>
    <description>Patient will be given the VAS on the source document in order to draw on the scale&#xD;
Blinded investigators</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay (LOS)</measure>
    <time_frame>12 months postoperatively</time_frame>
    <description>-Measured in days (24 hours)&#xD;
• Automatic data capture on discharge by the hospital EMR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morphine equivalent doses</measure>
    <time_frame>12 months postoperatively</time_frame>
    <description>-Non-study narcotics taken by patients on the floor are converted to morphine equivalent doses&#xD;
Morphine equivalent doses are compared between the two groups daily for the first 48h&#xD;
Data extracted from hospital EMR on discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications/Adverse events</measure>
    <time_frame>12 months postoperatively</time_frame>
    <description>-Ketorolac-related short term in-hospital complications: GI ulceration and bleeding, GI perforation, PO bleeding, acute renal failure, anaphylactic/anaphylactoid reactions, liver failure&#xD;
Collected by investigators daily during round&#xD;
Document on the source document</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life - long term</measure>
    <time_frame>12 months and/or 24 months postoperatively</time_frame>
    <description>Oswestry Disability Index (ODI)&#xD;
We will administer validated scales (ODI)&#xD;
Face-to -face interview during clinic visit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Thoracolumbar Spinal Fusions</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Drug: Placebo Saline 1 ml IV Q6H</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ketorolac 15 mg (15mg/ml) IV Q6H</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>1 ml saline IV Q6H</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketorolac</intervention_name>
    <description>15 mg (15 mg/ml) IV Q6H</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years of age&#xD;
&#xD;
          -  Elective thoracolumbar posterior lumbar instrumented interbody fusion&#xD;
&#xD;
          -  Minimally invasive spine surgery (MIS)&#xD;
&#xD;
          -  3 or fewer levels&#xD;
&#xD;
          -  Bone Morphogenetic Protein (BMP) use in interbody fusion (1.05mg/level or less)&#xD;
&#xD;
          -  Consent to study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active tobacco smoker or history of tobacco smoking in the past 6 weeks&#xD;
&#xD;
          -  Previous history of surgery at operative level(s)&#xD;
&#xD;
          -  History of chronic inflammatory/rheumatological condition&#xD;
&#xD;
          -  History of systemic steroid use in the past 3 months&#xD;
&#xD;
          -  Auto/Workers' compensation patients&#xD;
&#xD;
          -  Traumatic pathology at the operative levels&#xD;
&#xD;
          -  Infection at the operative levels&#xD;
&#xD;
          -  Tumor at the operative levels&#xD;
&#xD;
          -  Major psychiatric illness as diagnosed by psychiatrists and on major anti-&#xD;
             psychotic/depressants&#xD;
&#xD;
          -  Patients on chemotherapeutic agents in the last 6 months&#xD;
&#xD;
          -  Patients who has a history of allergy to Ketorolac&#xD;
&#xD;
          -  Patients with a history of chemical addiction requiring professional rehabilitation&#xD;
             and/or assistance&#xD;
&#xD;
          -  Patients with current creatinine &gt; 1.5mg/dl&#xD;
&#xD;
          -  Patients with history of coagulopathy&#xD;
&#xD;
          -  Patients with history of hepatic impairment&#xD;
&#xD;
          -  Patients with uncontrolled cardiovascular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Doris Tong, MD</last_name>
    <role>Study Director</role>
    <affiliation>Michigan Spine and Brain Surgeons</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Doris Tong, MD</last_name>
    <phone>(248) 763-2380</phone>
    <email>doris.tong@michiganspineandbrainsurgeons.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chad Claus, DO</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Providence-Providence Park, Southfield</name>
      <address>
        <city>Southfield</city>
        <state>Michigan</state>
        <zip>48075</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>April 18, 2023</last_update_submitted>
  <last_update_submitted_qc>April 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketorolac</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03278691
org study id: IRB # 1072359
nct id: NCT03278691
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Fusion Construct X-Ray
time frame: 6 months postoperatively
description: 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.
measure: Fusion Construct X-Ray
time frame: 12 months postoperatively
description: 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.
measure: Fusion Construct X-Ray
time frame: 24 months postoperatively
description: 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.
measure: Visual Analogue Scale (VAS) for pain
time frame: Every 8 hours x 48 hours postoperatively
description: Patient will be given the VAS on the source document in order to draw on the scale
Blinded investigators
measure: Length of Stay (LOS)
time frame: 12 months postoperatively
description: -Measured in days (24 hours)
• Automatic data capture on discharge by the hospital EMR
measure: Morphine equivalent doses
time frame: 12 months postoperatively
description: -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
measure: Complications/Adverse events
time frame: 12 months postoperatively
description: -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
measure: Quality of life - long term
time frame: 12 months and/or 24 months postoperatively
description: Oswestry Disability Index (ODI)
We will administer validated scales (ODI)
Face-to -face interview during clinic visit
arm group label: Placebo
arm group type: Placebo Comparator
description: Drug: Placebo Saline 1 ml IV Q6H
arm group label: Intervention
arm group type: Experimental
description: Ketorolac 15 mg (15mg/ml) IV Q6H
intervention type: Drug
intervention name: Saline
description: 1 ml saline IV Q6H
arm group label: Placebo
intervention type: Drug
intervention name: Ketorolac
description: 15 mg (15 mg/ml) IV Q6H
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Doris Tong, MD
role: Study Director
affiliation: Michigan Spine and Brain Surgeons
last name: Doris Tong, MD
phone: (248) 763-2380
email: doris.tong@michiganspineandbrainsurgeons.com
last name: Chad Claus, DO
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Ketorolac
sharing ipd: No