Ketorolac on Posterior Thoracolumbar Spinal Fusions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-03

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Thoracolumbar Spinal Fusions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Drug: Placebo Saline 1 ml IV Q6H

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

1 ml saline IV Q6H

Intervention

Ketorolac 15 mg (15mg/ml) IV Q6H

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

15 mg (15 mg/ml) IV Q6H

Interventions

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Saline

1 ml saline IV Q6H

Intervention Type DRUG

Ketorolac

15 mg (15 mg/ml) IV Q6H

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes