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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04246541
Recruitment Status : Recruiting
First Posted : January 29, 2020
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Karns, MD., University Hospitals Cleveland Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Meniscus Tear, Tibial Pain, Postoperative Postoperative Complications Ketorolac Adverse Reaction Opioid Use Drug: Ketorolac Drug: Oxycodone-Acetaminophen Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Control
Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery
Drug: Oxycodone-Acetaminophen
Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.

Experimental: Ketorolac
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
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.




Primary Outcome Measures :
  1. Pain levels recorded with a visual analogue scale [ Time Frame: up to 8 weeks post-operatively ]
    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.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04246541


Contacts
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Contact: Lakshmanan Sivasundaram, MD 2168443233 lakshmanan.sivasundaram@uhhospitals.org

Locations
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United States, Ohio
UH Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Lakshmanan Sivasundaram, MD         
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Michael Karns, MD University Hospitals Cleveland Medical Center
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Responsible Party: Michael Karns, MD., Principal Investigator, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT04246541    
Other Study ID Numbers: STUDY20181100
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020

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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
Keywords provided by Michael Karns, MD., University Hospitals Cleveland Medical Center:
ketorolac
meniscus tear
analgesics
pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Tibial Meniscus Injuries
Pathologic Processes
Pain
Neurologic Manifestations
Leg Injuries
Wounds and Injuries
Acetaminophen
Ketorolac
Acetaminophen, hydrocodone drug combination
Oxycodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action