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临床试验/NCT04522206
NCT04522206已完成4 期

An Analysis of the Efficacy of a Pre-Emptive Multimodal Pain Regimen in Reducing Acute Post-Operative Pain and Narcotic Pain Medication Requirements in Spine Surgery

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年8月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
44
试验地点
1
主要终点
Visual Analogue Scale (VAS) for Pain

研究概览

简要总结

The aim of this study is to investigate the hypothesis that multimodal pain regimen (consisting of acetaminophen, celecoxib, gabapentin, and oxycodone) administered pre-operatively before elective spine surgery significantly decreases acute pain post-operatively as well as decreasing requirements of post-op opioids for pain control in PACU as compared to patients undergoing elective spine surgery without a pre-operative pain regimen.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Undergoing elective spine surgery at NYU Winthrop
  • Age over 18 years

排除标准

  • History of neuromuscular disorders
  • History of inflammatory arthropathies
  • History of spine metastases or active cancer in spine
  • Medical History including any of the following: renal dysfunction, gastric ulcers, hepatic dysfunction, coagulopathic/bleeding disorders, prior adverse or allergic reactions to any of the medications in the study
  • Age less than 18 years

研究组 & 干预措施

Patients undergoing elective spine surgery

Experimental

干预措施: Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone (Drug)

结局指标

主要结局

Visual Analogue Scale (VAS) for Pain

时间窗: 24 hours

VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.

Opioid Sparing and Rescue Time

时间窗: 24 hours

Time interval from patient extubation to time when pain medication is first demanded in the PACU

次要结局

  • Length of Stay in Hospital(Up to 12 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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