Are Opioids Needed: A Double-Blinded, Randomized Controlled Trial and Examination of Predictors of Opioid Use Following ACL Reconstruction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 3
- 主要终点
- Pain Level: Numeric Rating Scale
研究概览
简要总结
As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons must revisit pain management protocols to reduce unnecessary opioid prescriptions. The long-term goal is to reduce opioid use and residual opioids in circulation.
详细描述
As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons must revisit pain management protocols to reduce unnecessary opioid prescriptions. The long-term goal is to reduce opioid use and residual opioids in circulation. The purposes are to 1) conduct a double-blinded randomized controlled trial to determine the effectiveness of opioid versus non-opioid medications on post-surgical pain, and 2) examine predictors of opioid usage in individuals following Anterior Cruciate ligament (ACL) reconstruction. Patients will use an innovative Smartphone application to track pain and medication usage. Additionally, patients will complete quality of life and pain catastrophizing questionnaires, as well as undergo pain threshold testing, to be used in a model to determine predictors of greater post-surgical opioid use. This study will provide information on non-opioid alternatives and specific predictors of post-surgical opioid use that can be used to develop prescribing protocols. These findings will help orthopaedic surgeons make informed decisions when tailoring individualized prescriptions for patients following ACL reconstruction. Importantly, findings will be readily translatable into research to reduce opioid use in other orthopaedic surgical cohorts as well. Our ultimate goal is to lessen the burden of the opioid epidemic on not only our orthopaedic patients, but also society, by minimizing the number of opioids left in circulation.
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
- Double (Participant, Investigator)
盲法说明
Both participants and PI (orthopaedic surgeon) will be blinded. Placebo pills will be closely matched to oxycodone pills, so patients will not know to which group they are allocated. The PI will be blinded to group allocation.
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •Aged 14-40 years
- •Scheduled for primary (Anterior cruciate ligament) ACL reconstruction using quadriceps tendon autograft.
排除标准
- •Revision and/or contralateral ACL reconstruction procedures
- •Allergies to local anesthetics
- •Chronic pain medication use
- •Weight <50 kg, local infections
- •Known coagulopathies,
- •Liver dysfunction or renal failure
研究组 & 干预措施
Oxycodone Arm
Patients in this opioid group will receive 15 oral opioid tablets (5 mg oxycodone) Patients will also receive 8 "rescue" medications, in the Oxycodone arm will be placebo "rescue" medications.
All participants will also receive the following as part of standard of care:
- Oral non-opioid (1000 mg acetaminophen), every 8 hours.
- Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery.
- Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block.
- Intraoperative education on post-surgical pain management.
干预措施: Oxycodone (Drug)
Placebo Arm
Patients in placebo group will receive 15 placebo tablets. All patients will also receive 8 "rescue" medications: Patients who randomize to the non-opioid arm will receive 5mg oxycodone "rescue" tablets.
All participants will also receive the following as part of standard of care:
- Oral non-opioid (1000 mg acetaminophen), every 8 hours.
- Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery.
- Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block.
- Intraoperative education on post-surgical pain management.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Pain Level: Numeric Rating Scale
时间窗: Postoperative days 0-6
Patients will record pain levels on Numeric Rating Scale 1-10, where 1 is minimal pain and 10 is associated with highest level of pain (worse outcome).
次要结局
未报告次要终点