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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04246541
• Other study ID #: STUDY20181100
• Status: Completed
• Phase: Phase 3
• Start date: April 23, 2019
• Est. completion date: September 12, 2021

Study information

• Verified date: March 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 12, 2021
• Est. primary completion date: September 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• Oxycodone-Acetaminophen
Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.

Locations

Country	Name	City	State
United States	UH Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Narcotic Medication Consumed	Number of oxycodone- acetaminophen tablets consumed	up to 5 days postoperatively