Evaluation of Open-Label Conditioned Placebo Analgesia for Postoperative Opioid Reduction Following Spinal Fusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- self administration of PRN opioids
研究概览
简要总结
This research aims to understand the impact of conditioned open label placebo (COLP) on opioid consumption and pain after surgery. The hypothesis being tested is that by pairing a non-deceptive placebo pill with regularly prescribed pain killers after surgery, will allow reduction in opioids taken while maintaining the same level of analgesia.
详细描述
Participants will be enrolled at preoperative clinic.
Inclusion criteria:
- aged 18-75 years
- scheduled for spinal fusion surgery
- able to comprehend and willingness to participate in COLP
- willingness to undergo psychophysical and psychosocial testing
- willingness to participate in long-term follow-up.
Exclusion criteria:
- delirium, psychosis, or other cognitive impairment limiting completion of study procedures
- non-English speaking
- contraindication to opioid usage
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) aged 18-75 years, (2) scheduled for spinal fusion surgery up to, and including 4 levels, (3) able to comprehend and willingness to participate in COLP, (4) willingness to undergo psychophysical and psychosocial testing (5) willingness to participate in long-term follow-up.
排除标准
- •(1) delirium, psychosis, or other cognitive impairment limiting completion of study procedures (2) non-English
结局指标
主要结局
self administration of PRN opioids
时间窗: day 3-17
daily report of post-discharge opioid use in sub-acute postoperative period, converted into morphine milligram equivalents
acute postoperative pain
时间窗: day 3-17
daily brief pain inventory (BPI)
次要结局
未报告次要终点
研究者
Kristin Schreiber
Assistant Professor, Principle Investigator
Brigham and Women's Hospital