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Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion

2022年7月10日更新者：Serena Hu、Stanford University

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

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (预期的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Akaila Cabell, MD'
电话号码：2629301528
邮箱：acabell4@stanford.edu

学习地点

美国
- California
  - Redwood City、California、美国、94063
    - 招聘中
    - Stanford Hospital and Clinics
    - 接触：
      
      Susmita Chatterjee
      
      电话号码：650-497-9271
      
      邮箱：susmitac@stanford.edu

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：其他
分配：随机化
介入模型：并行分配
屏蔽：单身的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Opioid Taper Group Patients randomized to the taper group will have baseline pain score, opioid medication use, and patient reported outcomes 4-6 weeks prior to elective thoracolumbar, lumbar, or lumbosacral spinal fusion surgery. They will receive a scheduled tapering protocol, with a goal of 10-15% reduction in their weekly opioid use, along with weekly phone calls from a study coordinator assessing their ability to taper and pain scores. After surgery, they will receive 6 weekly phone calls from the coordinator, to assess their postoperative opioid medication use and pain scores. At the 6th week phone call, and 3 month and 6 month clinic postoperative clinic visits, they will also repeat patient reported outcome measures.	行为的：Spinal Fusion Preoperative Opioid Taper Guided weekly opioid pain medication reduction via telephone calls prior to elective spinal fusion surgery.
有源比较器：Control Group Patients randomized to the control group will have baseline pain score, opioid medication use, and patient reported outcomes 4-6 weeks prior to elective thoracolumbar, lumbar, or lumbosacral spinal fusion surgery. They will receive no recommendation or guidance in their preoperative opioid pain medication use, but will received weekly phone calls from a study coordinator assessing their preoperative pain scores. After surgery, they will receive 6 weekly phone calls from the coordinator, to assess their postoperative opioid medication use and pain scores. At the 6th week phone call, and 3 month and 6 month clinic postoperative clinic visits, they will also repeat patient reported outcome measures.	其他：Non-taper Control Weekly phone calls prior to elective spinal fusion surgery, without opioid pain medication reduction recommendation or guidance.

参与者组/臂

干预/治疗

实验性的：Opioid Taper Group

Patients randomized to the taper group will have baseline pain score, opioid medication use, and patient reported outcomes 4-6 weeks prior to elective thoracolumbar, lumbar, or lumbosacral spinal fusion surgery. They will receive a scheduled tapering protocol, with a goal of 10-15% reduction in their weekly opioid use, along with weekly phone calls from a study coordinator assessing their ability to taper and pain scores. After surgery, they will receive 6 weekly phone calls from the coordinator, to assess their postoperative opioid medication use and pain scores. At the 6th week phone call, and 3 month and 6 month clinic postoperative clinic visits, they will also repeat patient reported outcome measures.

行为的：Spinal Fusion Preoperative Opioid Taper

Guided weekly opioid pain medication reduction via telephone calls prior to elective spinal fusion surgery.

有源比较器：Control Group

Patients randomized to the control group will have baseline pain score, opioid medication use, and patient reported outcomes 4-6 weeks prior to elective thoracolumbar, lumbar, or lumbosacral spinal fusion surgery. They will receive no recommendation or guidance in their preoperative opioid pain medication use, but will received weekly phone calls from a study coordinator assessing their preoperative pain scores. After surgery, they will receive 6 weekly phone calls from the coordinator, to assess their postoperative opioid medication use and pain scores. At the 6th week phone call, and 3 month and 6 month clinic postoperative clinic visits, they will also repeat patient reported outcome measures.

其他：Non-taper Control

Weekly phone calls prior to elective spinal fusion surgery, without opioid pain medication reduction recommendation or guidance.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Change in Postoperative Opioid Pain Medication Dose 大体时间：Weekly, month 3, month 6	Weekly average opioid medication use in morphine equivalent dosage (MED)	Weekly, month 3, month 6
Change in Numeric Pain Scale Score 大体时间：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.	Weekly, month 3, month 6
Change from baseline Patient Reported Outcome Measures (PROMs) 大体时间：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.	Weekly, month 3, month 6

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Stanford University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年9月9日

初级完成 (预期的)

2024年7月1日

研究完成 (预期的)

2024年7月1日

研究注册日期

首次提交

2019年6月3日

首先提交符合 QC 标准的

2019年9月18日

首次发布 (实际的)

2019年9月19日

研究记录更新

最后更新发布 (实际的)

2022年7月12日

上次提交的符合 QC 标准的更新

2022年7月10日

最后验证

2022年7月1日

Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion