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

NCT04246541 | Completed Phase 3 Results FDA Drug

• 1 other identifier: STUDY20181100
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

ketorolac; meniscus tear; analgesics; pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control

EXPERIMENTAL

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

Drug: Oxycodone-Acetaminophen

Ketorolac

EXPERIMENTAL

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

Interventions

Ketorolac 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.

Ketorolac

Oxycodone-Acetaminophen DRUG

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

Control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 and 89 years of age
• Patients undergoing primary arthroscopic meniscus surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Tibial Meniscus Injuries; Pain, Postoperative; Postoperative Complications; Pain

Interventions

Ketorolac; oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

single institution study not blinded

Results Point of Contact

• Title: Dr. Michael Karns
• Organization: University Hospitals Cleveland Medical Center

michael.karns@uhhospitals.org

216-844-7200

Study Officials

• Michael Karns, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 29, 2020
• Study Start: April 23, 2019
• Primary Completion: September 12, 2021
• Study Completion: September 12, 2021
• Last Updated: March 3, 2022
• Results First Posted: December 1, 2021

Record last verified: 2022-03

Locations

US (1)