Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 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
- 否
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)
研究组 & 干预措施
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.
干预措施: Spinal Fusion Preoperative Opioid Taper (Behavioral)
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.
干预措施: Non-taper Control (Other)
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
Serena Hu
Professor of Orthopaedic Surgery
Stanford University