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Ketorolac on Posterior Thoracolumbar Spinal Fusions

Primary Purpose

Thoracolumbar Spinal Fusions

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Saline
Ketorolac
Sponsored by
Ascension South East Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracolumbar Spinal Fusions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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
  • 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

Sites / Locations

  • Providence-Providence Park, SouthfieldRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Intervention

Arm Description

Drug: Placebo Saline 1 ml IV Q6H

Ketorolac 15 mg (15mg/ml) IV Q6H

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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
Length of Stay (LOS)
-Measured in days (24 hours) • Automatic data capture on discharge by the hospital EMR
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
Complications/Adverse events
-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
Quality of life - long term
Oswestry Disability Index (ODI) We will administer validated scales (ODI) Face-to -face interview during clinic visit

Full Information

First Posted
August 24, 2017
Last Updated
April 18, 2023
Sponsor
Ascension South East Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03278691
Brief Title
Ketorolac on Posterior Thoracolumbar Spinal Fusions
Official Title
The Effect of Ketorolac on Posterior Thoracolumbar Spinal Fusions: a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascension South East Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracolumbar Spinal Fusions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo Saline 1 ml IV Q6H
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Ketorolac 15 mg (15mg/ml) IV Q6H
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
1 ml saline IV Q6H
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
15 mg (15 mg/ml) IV Q6H
Primary Outcome Measure Information:
Title
Fusion Construct X-Ray
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.
Time Frame
6 months postoperatively
Title
Fusion Construct X-Ray
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.
Time Frame
12 months postoperatively
Title
Fusion Construct X-Ray
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.
Time Frame
24 months postoperatively
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) for pain
Description
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
Title
Length of Stay (LOS)
Description
-Measured in days (24 hours) • Automatic data capture on discharge by the hospital EMR
Time Frame
12 months postoperatively
Title
Morphine equivalent doses
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
Time Frame
12 months postoperatively
Title
Complications/Adverse events
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
Time Frame
12 months postoperatively
Title
Quality of life - long term
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doris Tong, MD
Phone
(248) 763-2380
Email
doris.tong@michiganspineandbrainsurgeons.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chad Claus, DO
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris Tong, MD
Organizational Affiliation
Michigan Spine and Brain Surgeons
Official's Role
Study Director
Facility Information:
Facility Name
Providence-Providence Park, Southfield
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30670528
Citation
Claus CF, Lytle E, Tong D, Sigler D, Lago D, Bahoura M, Dosanjh A, Lawless M, Slavnic D, Kelkar P, Houseman C, Bono P, Richards B, Soo TM. The effect of ketorolac on posterior thoracolumbar spinal fusions: a prospective double-blinded randomised placebo-controlled trial protocol. BMJ Open. 2019 Jan 21;9(1):e025855. doi: 10.1136/bmjopen-2018-025855.
Results Reference
derived

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Ketorolac on Posterior Thoracolumbar Spinal Fusions

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