Opioid Tapering After Spine Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)
研究概览
简要总结
The effect of a tapering plan combined with telephone counselling to assist patients in opioid tapering after surgery remains unexplored. A prospective, randomized controlled trial investigating the effect of a tapering plan in combination with telephone counselling in patients scheduled for spine surgery on a degenerative basis is therefore conducted.
详细描述
Background with aim:
Preoperative opioid-use is one of the strongest predictors for not tapering off opioids after discharge from surgery. In qualitative studies on chronic opioid use, patients call for further help and assistance in tapering opioids. The aim of this study is to investigate the effect of receiving a tapering plan at discharge and telephone counselling one week after discharge on short and long-term opioid-use in preoperative opioid-users who undergo scheduled spine surgery.
Methods:
One-hundred and ten adult patients scheduled for spine surgery will be included in an investigator-initiated, prospective, randomized, controlled trial with two arms: an intervention arm (receiving tapering plan at discharge and telephone counselling on opioid tapering 5-7 days after discharge) or a control arm (receiving no tapering plan or telephone counselling). The study is approved by the Danish Data Protection Agency (1-16-02-211-19) and the Central Denmark Region Committees on Health Research Ethics (1-10-72-138-19).
Hypothesis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Daily opioid consumption at least 14 days before surgery
- •Planned degenerative cervical, thoracic or lumbar spine surgery
排除标准
- •Severe physical co-morbidity or inability to participate (dementia, language problems or mental illness)
结局指标
主要结局
Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)
时间窗: 0-30 days after discharge
次要结局
- Withdrawal symptoms (yes/no) during opioid tapering(0-30 days after discharge)
- Pain-related contacts to the primary and/or secondary health care system (yes/no)(0-14 days after discharge)
- Number of patients tapering off to zero measured in total MME(0-365 days after discharge)
- Patient satisfaction (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied)(0-14 days after discharge)
- Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)(0-365 days after discharge)
研究者
Peter Gaarsdal Uhrbrand
MD, PhD Student
Aarhus University Hospital