Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pain Levels Recorded With a Visual Analogue Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between 18 and 89 years of age
- •Patients undergoing primary arthroscopic meniscus surgery
排除标准
- •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
研究组 & 干预措施
Control
Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery
干预措施: Oxycodone-Acetaminophen (Drug)
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.
干预措施: Ketorolac (Drug)
结局指标
主要结局
Pain Levels Recorded With a Visual Analogue Scale
时间窗: 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
时间窗: up to 5 days postoperatively
Number of oxycodone- acetaminophen tablets consumed
次要结局
未报告次要终点
研究者
Michael Karns, MD.
Principal Investigator
University Hospitals Cleveland Medical Center
