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

NCT ID: NCT04246541

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-23
• Study Completion Date: 2021-09-12

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: EXPERIMENTAL

Oxycodone-Acetaminophen

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Ketorolac

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Oxycodone-Acetaminophen

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Karns, MD.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Karns, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

UH Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY20181100

Identifier Type: -

Identifier Source: org_study_id