Ketorolac on Posterior Thoracolumbar Spinal Fusions

April 18, 2023 updated by: Ascension South East Michigan

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo Saline 1 ml IV Q6H
Drug: Saline
1 ml saline IV Q6H
Experimental: Intervention
Ketorolac 15 mg (15mg/ml) IV Q6H
Drug: Ketorolac
15 mg (15 mg/ml) IV Q6H

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fusion Construct X-Ray
Time Frame: 6 months postoperatively
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.
6 months postoperatively
Fusion Construct X-Ray
Time Frame: 12 months postoperatively
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.
12 months postoperatively
Fusion Construct X-Ray
Time Frame: 24 months postoperatively
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.
24 months postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS) for pain
Time Frame: Every 8 hours x 48 hours postoperatively
  • Patient will be given the VAS on the source document in order to draw on the scale
  • Blinded investigators
Every 8 hours x 48 hours postoperatively
Length of Stay (LOS)
Time Frame: 12 months postoperatively

-Measured in days (24 hours)

• Automatic data capture on discharge by the hospital EMR
12 months postoperatively
Morphine equivalent doses
Time Frame: 12 months postoperatively

-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
12 months postoperatively
Complications/Adverse events
Time Frame: 12 months postoperatively

-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
12 months postoperatively
Quality of life - long term
Time Frame: 12 months and/or 24 months postoperatively

Oswestry Disability Index (ODI)

  • We will administer validated scales (ODI)
  • Face-to -face interview during clinic visit
12 months and/or 24 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ascension South East Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB # 1072359

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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