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临床试验/NCT04725357
NCT04725357Unknown3 期

A Randomized Comparison of Meloxicam to Opioids Following Arthroscopic Labrum Repairs of the Shoulder

Rothman Institute Orthopaedics1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2021年1月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
96
试验地点
1
主要终点
Total Analgesic use

研究概览

简要总结

The opioid epidemic continues to be a major concern, with orthopedic surgeons being among the top prescribers of opioids. Studies evaluating these practices found that opioids are overprescribed, even for common procedures. Patients undergoing arthroscopic labrum repair of the shoulder were found to have an average of 20 pills left over after surgery. Many strategies have been developed to tackle overprescribing and have found success, including no opioid protocols for carpal tunnel release. The purpose of this study is to examine if meloxicam alone provides similar patient reported outcomes to opioids following arthroscopic labrum repair of the shoulder.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for arthroscopic labrum repair of the shoulder

排除标准

  • History of opioid, acetaminophen, NSAID or local anesthetic allergy or intolerance, or contraindications to these medications.
  • Currently on long-term preoperative narcotics
  • Scheduled for revision arthroscopic repairs of the shoulder
  • Unable/unwilling to consent for enrollment
  • Unable to complete postoperative surveys
  • History of chronic pain syndromes (fibromyalgia, chronic diffuse MSK pain, etc)
  • Patients under the age of 18
  • Pregnant or breastfeeding women
  • Scheduled for concurrent procedures

研究组 & 干预措施

Arthroscopic Labral Repair + postoperative Meloxicam

Experimental

After surgery participants will receive a prescription of 20 pills of 15 mg Meloxicam

干预措施: Meloxicam 15 mg (Drug)

Arthroscopic Labral Repair + postoperative Meloxicam

Experimental

After surgery participants will receive a prescription of 20 pills of 15 mg Meloxicam

干预措施: Preoperative Interscalene Nerve Block (Procedure)

Arthroscopic Labral Repair + postoperative Meloxicam

Experimental

After surgery participants will receive a prescription of 20 pills of 15 mg Meloxicam

干预措施: arthroscopic labral repair (Procedure)

Arthroscopic Labral Repair without Meloxicam

Active Comparator

After surgery participants will receive a prescription of 20 pills of 5/300 mg vicodin (hydrocodone/acetaminophen)

干预措施: Preoperative Interscalene Nerve Block (Procedure)

Arthroscopic Labral Repair without Meloxicam

Active Comparator

After surgery participants will receive a prescription of 20 pills of 5/300 mg vicodin (hydrocodone/acetaminophen)

干预措施: arthroscopic labral repair (Procedure)

结局指标

主要结局

Total Analgesic use

时间窗: 14 days

Participants will be given a survey asking about number of pills taken

Postoperative Pain Control

时间窗: 14 days

Measured by the Numerical Rating Scale (NRS) pain score daily after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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