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临床试验/NCT04138264
NCT04138264已完成不适用

Opioid Consumption After Orthopaedic Surgery: Prospective Randomized Trial on the Effects of Pre-Operative Counseling

Rothman Institute Orthopaedics2 个研究点 分布在 1 个国家目标入组 237 人开始时间: 2018年6月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
237
试验地点
2
主要终点
Number of pills consumed

研究概览

简要总结

Postoperative pain management and opioid consumption following outpatient orthopaedic surgery may be influenced by a number of variables including knowledge of safe opioid use. A prospective randomized study is designed to understand the effect of preoperative opioid counseling on postoperative opioid consumption and the typical opioid consumption patterns following common outpatient orthopaedic surgeries. The hypothesis was that patients who received preoperative opioid counseling will consume less postoperative opioid medication and experience greater satisfaction with pain management.

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 (Investigator)

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

  • Patients undergoing shoulder, elbow, wrist, knee, foot, and/or ankle surgery

排除标准

  • male of female less than 18 years old
  • patients schedule to undergo inpatient procedures
  • patients undergoing surgeries distal to the wrist
  • patients undergoing surgeries under local anesthesia only

研究组 & 干预措施

Peroperative counseling

Active Comparator

干预措施: Preoperative opioid counseling (Other)

No preoperative counseling

No Intervention

结局指标

主要结局

Number of pills consumed

时间窗: Up to 6 weeks

Patients asked to keep daily diary which includes number of pills consumed during the post-operative period

次要结局

  • Patient satisfaction with pain management: 5 point Likert Scale(Up to 6 weeks)
  • Morphine equivalents (MEQ)(Up to 6 weeks)
  • Visual Analog Scale (pain) Pain(Up to 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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