Ketorolac vs Oxycodone for Great Toe Arthrodesis

Study Overview
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Brief Summary
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This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.

Detailed Description
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This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.

Official Title
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Effect of Ketorolac Administration on Post-operative Narcotic Utilization and Union Rates in Great Toe Arthrodesis

Conditions
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Arthrodesis

Intervention / Treatment
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* Drug: Oxycodone
* Drug: Ketorolac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 75 years. Women of childbearing potential must have a negative serum or urine pregnancy test results within 24 hours before the first dose of ketorolac. Primary elective great toe MTP arthrodesis (CPT 28750). Other forefoot procedures often performed in conjunction with toe fusion will be included (CPT codes 28308, 28285, 28270). Exclusion Criteria: Chronic pain syndrome, CRPS or fibromyalgia Revision procedures Use of allograft bone at the fusion site Tobacco use Diabetes Narcotic abuse or IV drug abuse Any CPT codes involving the midfoot, hindfoot, and/or ankle Unable to take NSAIDs secondary to medical comorbidities such as kidney disease (impaired renal function with CrCl ≤ 50 ml/min) or gastric ulcers Weight < 50 kg Does not speak or read English If pregnant or planning to become pregnant or breastfeeding Non-independent dweller (prisoner)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (Control group) - Oxycodone only<br>Subjects randomized to this group will receive oxycodone for postop pain management (standard of care). | Drug: Oxycodone<br>* Subjects randomized to the control group will receive oxycodone for postop pain management (standard of care).<br>|
| Experimental: Group 2 (Treatment group) - Oxycodone and Ketorolac<br>Subjects randomized to this group will receive oxycodone and ketorolac for postop pain management. | Drug: Oxycodone<br>* Subjects randomized to the control group will receive oxycodone for postop pain management (standard of care).<br>Drug: Ketorolac<br>* Subjects randomized to the treatment group will receive oxycodone and ketorolac for postop pain management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores - collected at baseline (standard of care) and for the study using a study survey on days 3, 7, and 14 after surgery. | To study if postop ketorolac provides effective pain relief and helps reduce the need to take oxycodone. Participants will complete a short survey on Days 3, 7, and 14 after surgery. Participants will be asked to provide VAS pain scores, on a scale of 1-10, for the past 24 hours on Days 3, 7, and 14 after surgery. | From baseline to 14 days after the surgery | 
| Quantitative pain management - measured using a study survey. | To study if postop ketorolac provides effective pain relief and helps reduce the need to take oxycodone. Participants will complete a short survey on Days 3, 7, and 14 after surgery. The survey will ask the following set of questions- number of pills (oxycodone and/or ketorolac) consumed if the pain medicine(s) needed to be refilled discontinuation date & reason side effects, if any the effectiveness of the pain medicine(s) preference for ketorolac or oxycodone, if applicable | 14 days after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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big toe arthrodesis, big toe, joint fusion