Ketorolac on Posterior Thoracolumbar Spinal Fusions

Study Overview
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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.

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

Conditions
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Thoracolumbar Spinal Fusions

Intervention / Treatment
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* Drug: Saline
* Drug: Ketorolac


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Drug: Placebo Saline 1 ml IV Q6H | Drug: Saline<br>* 1 ml saline IV Q6H<br>|
| Experimental: Intervention<br>Ketorolac 15 mg (15mg/ml) IV Q6H | Drug: Ketorolac<br>* 15 mg (15 mg/ml) IV Q6H<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months postoperatively | 
| 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. | 12 months postoperatively | 
| 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. | 24 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Every 8 hours x 48 hours postoperatively | 
| Length of Stay (LOS) | -Measured in days (24 hours) • Automatic data capture on discharge by the hospital EMR | 12 months postoperatively | 
| 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 | 12 months postoperatively | 
| 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 | 12 months postoperatively | 
| Quality of life - long term | Oswestry Disability Index (ODI) We will administer validated scales (ODI) Face-to -face interview during clinic visit | 12 months and/or 24 months postoperatively |