Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery

Study Overview
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Brief Summary
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The utilization of arthroscopic surgery to treat meniscus injuries has continued to increase in recent years, partly due to a younger, more active population, and improved technology and technique. However, pain management in the post-operative period is critical to the ability to perform this procedure as an outpatient surgery. Traditionally, oral narcotic agents have been the preferred analgesic postoperatively in orthopaedic surgery. However, these agents are associated with several side effects, including nausea/vomiting, constipation, and somnolence. In addition, opioid agents have a significant potential for abuse in comparison to non-narcotic analgesics. In light of the rising opioid epidemic and nationwide initiatives to limit narcotic usage, surgeons must explore alternate pain modalities in the acute postoperative period. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties.1 Multiple prior studies have examined the beneficial effect of oral and intravenous (IV) ketorolac as an analgesic in the postoperative period,1-3 including arthroscopic meniscus surgery. However, the beneficial effects of this agent following arthroscopic meniscus surgery have not been extensively described.

Official Title
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Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery

Conditions
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Meniscus Tear, Tibial, Pain, Postoperative, Postoperative Complications, Ketorolac Adverse Reaction, Opioid Use

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Oxycodone-Acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18 and 89 years of age Patients undergoing primary arthroscopic meniscus surgery Exclusion Criteria: Patients age less than 18 or greater than 89 years Illiterate or non-English speaking patients Patients with contraindications to ketorolac History of drug or alcohol abuse Chronic use of analgesic or psychotropic drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| Experimental: Control<br>Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery | Drug: Oxycodone-Acetaminophen<br>* Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.<br>|
| Experimental: Ketorolac<br>Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery. | Drug: Ketorolac<br>* Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Levels Recorded With a Visual Analogue Scale | Patients will record pain levels post-operatively using a visual analogue scale (VAS) ranging from 0 as the minimum value to 100 as the maximum value. A smaller VAS value will be considered a lower pain level. | 2 weeks postoperatively | 
| Narcotic Medication Consumed | Number of oxycodone- acetaminophen tablets consumed | up to 5 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketorolac, meniscus tear, analgesics, pain