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

Primary Purpose

Meniscus Tear, Tibial, Pain, Postoperative, Postoperative Complications

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Oxycodone-Acetaminophen
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniscus Tear, Tibial focused on measuring ketorolac, meniscus tear, analgesics, pain

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UH Cleveland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control

Ketorolac

Arm Description

Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery

Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery.

Outcomes

Primary Outcome Measures

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.
Narcotic Medication Consumed
Number of oxycodone- acetaminophen tablets consumed

Secondary Outcome Measures

Full Information

First Posted
January 24, 2020
Last Updated
March 1, 2022
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04246541
Brief Title
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery
Official Title
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
September 12, 2021 (Actual)
Study Completion Date
September 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniscus Tear, Tibial, Pain, Postoperative, Postoperative Complications, Ketorolac Adverse Reaction, Opioid Use
Keywords
ketorolac, meniscus tear, analgesics, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery
Arm Title
Ketorolac
Arm Type
Experimental
Arm Description
Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxycodone-Acetaminophen
Intervention Description
Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.
Primary Outcome Measure Information:
Title
Pain Levels Recorded With a Visual Analogue Scale
Description
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.
Time Frame
2 weeks postoperatively
Title
Narcotic Medication Consumed
Description
Number of oxycodone- acetaminophen tablets consumed
Time Frame
up to 5 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Karns, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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

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