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

Phase 3

Completed

• Conditions: Opioid Use; Postoperative Complications; Pain, Postoperative; Ketorolac Adverse Reaction; Meniscus Tear, Tibial
• Interventions: Drug: Oxycodone-Acetaminophen; Drug: Ketorolac

• Registration Number: NCT04246541
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-23
• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-29
• Primary Completion: 2021-09-12
• Study Completion: 2021-09-12
• Results First Submitted: 2021-10-21
• Results First Submitted QC: 2021-11-24
• Results First Posted: 2021-12-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Oxycodone-Acetaminophen	Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery
Ketorolac	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.

Primary Outcome Measures

Name	Time	Method
Pain Levels Recorded With a Visual Analogue Scale	2 weeks postoperatively	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	up to 5 days postoperatively	Number of oxycodone- acetaminophen tablets consumed

Trial Locations

Locations (1)

UH Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States