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临床试验/NCT04095624
NCT04095624已完成不适用

Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion: A Randomized Controlled Study

Stanford University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Change in Postoperative Opioid Pain Medication Dose

研究概览

简要总结

In light of the current opioid epidemic, there is an urgent need to address chronic opioid use prior to surgery before it is exacerbated by postoperative surgical pain. Our central hypothesis is that patients who taper their opioid use prior to surgery will have reduced postoperative opioid and pain medication usage, less postoperative pain, and improved patient reported outcomes relative to patients that do not taper prior to surgery. Our specific aims include: 1. Determine whether reducing patients' preoperative opioid usage through a structured tapering regimen reduces postoperative opioid and pain medication use. 2. Examine whether reducing patients' preoperative opioid usage through a structured tapering regimen reduces postoperative pain. 3. Determine whether reducing patients' preoperative opioid usage through a structured tapering regimen improves patient reported outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

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

  • 18 years of age or older
  • Indicated for lumbar, lumbosacral, or thoracolumbar spinal fusion surgery in the departments of Orthopedic Surgery and Neurosurgery
  • Daily opioid use for at least 4 weeks prior to the preoperative planning appointment

排除标准

  • Suboxone (buprenorphine) use
  • Unable to complete patient reported outcome measures (PROMs)

结局指标

主要结局

Change in Postoperative Opioid Pain Medication Dose

时间窗: Weekly, month 3, month 6

Weekly average opioid medication use in morphine equivalent dosage (MED)

Change from baseline Patient Reported Outcome Measures (PROMs)

时间窗: Weekly, month 3, month 6

PROMIS computer adaptive testing: global health, physical function, pain interference, pain behavior, depression, anxiety, fatigue, sleep disturbance, and satisfaction with social roles and activities.

Change in Numeric Pain Scale Score

时间窗: Weekly, month 3, month 6

Generic measure of average back pain, scale 0-10 with 0 being no pain and 10 being the most pain experienced.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Serena Hu

Professor of Orthopaedic Surgery

Stanford University

研究点 (2)

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