Safe Options for ACL Recovery: An Opioid Exposure Reduction Program for Anterior Cruciate Ligament Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Total morphine milligram equivalents administered
研究概览
简要总结
The purpose of the proposed work is to test a brief opioid exposure reduction program (ACL-OERP) designed to improve health literacy about opioid use following surgeries. This intervention is specifically designed to be used with patients (or for patients under 18, the patient and caregiver) undergoing Anterior Cruciate Ligament (ACL) reconstruction, a painful surgery that is often followed by at least 7 days of opioid medication.
详细描述
The goal of this study is to test whether the ACL-OERP intervention (vs. a treatment as usual [TAU] comparison) improves knowledge of (1) risks associated with opioid self-administration (development of tolerance, dangers of concomitant sedative use, taking as prescribed for safety), (2) expected pain following ACL reconstruction, (3) accurate pain assessment, (4) and weaning from opioid to non-narcotic analgesics.
There will be one control arm (TAU) and two intervention arms, both of which are experimental. Both will receive the ACL-OERP before surgery, and the second arm will also receive a "booster" intervention session of the intervention 3 days after surgery.
In addition, investigators wish to compare the amount of opioid self-administered in the intervention groups (vs. TAU comparison) to assess whether this knowledge reduces self-administration of opioid. The project will also examine whether the implementation of the booster intervention session in the third arm improves these outcomes compared to the other intervention arm.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting for a pre-operatory appointment at the study site for ACL reconstruction with patellar tendon autograft surgery.
- •Be able to return to the clinic at least one time within the first 10 days post-op.
排除标准
- •Under 12 years of age
- •Contraindication to opioids
- •Unable to understand intervention material in English
结局指标
主要结局
Total morphine milligram equivalents administered
时间窗: Assessed at 30 days post surgery
Cumulative morphine milligram equivalents self-administered following surgery; based upon pill counts
次要结局
- Knowledge of safe opioid use(Assessed at baseline and 7-days post surgery)
研究者
Karen Derefinko, PhD
Assistant Professor
University of Tennessee