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临床试验/NCT04278703
NCT04278703Unknown不适用

The Utilization of Opioid Medication Following ACL Reconstruction

Rothman Institute Orthopaedics1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2019年2月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
192
试验地点
1
主要终点
Post-operative pain

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of a post-operative opioid pain 18 management protocol for anterior cruciate ligament reconstruction (ACLR).

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
Single (Participant)

入排标准

接受健康志愿者

入选标准

  • All patients undergoing primary ACLR for ACL tear, including patients with concomitant 76 meniscectomy or meniscal repair.

排除标准

  • Concomitant procedure other than meniscectomy or meniscal repair.
  • ACL revision
  • History of chronic pre-operative opioid use
  • History of substance abuse
  • Workmen's compensation claims
  • Pregnancy

研究组 & 干预措施

15 opioid tablets perscribed

Active Comparator

For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain

干预措施: oxycodone (Drug)

25 opioid tablets perscribed

Active Comparator

For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain

干预措施: oxycodone (Drug)

35 opioid tablets perscribed

Active Comparator

For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain

干预措施: oxycodone (Drug)

结局指标

主要结局

Post-operative pain

时间窗: 14 days post-operative

Post-operative pain as reported by patients on a 0-10 VAS pain scale. 0 is no pain and 10 is worst pain imaginable

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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