Novel Non-opioid Post-surgical Pain Treatment in Females
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Post-Surgical Pain using Numeric Rating Scale (NRS)
研究概览
简要总结
This study aims to determine if treatment with Carbidopa/Levodopa and Naproxen in females (biological sex) with acute pain after a bunionectomy or toe fusion (24hrs, 48hrs and 5 days) will reduce pain when compared with females receiving Placebo and Naproxen.
详细描述
Acute post-surgical pain remains commonly treated with opioids. Although such treatments are efficacious, they can lead to opioid dependency. Disturbingly, opioid abuse often began as a direct consequence of prescription medications, primarily for pain management, and post-surgical pain management. Recent studies in from Apkarian lab suggest that the combination of dopamine and non-steroidal anti-inflammatory may be a safe, tolerable and efficacious novel post-surgical pain treatment option.
Therefore, the main hypothesis is: patients treated with Carbidopa/Levodopa and Naproxen will show a statistically significant decrease in post-surgical pain when compared with control intervention (Placebo plus Naproxen (250mg)). This will be done through a double-blind, randomized, placebo-controlled, parallel-group trial of the pharmacological treatment Carbidopa/Levodopa for females (N = 60) undergoing a bunionectomy or toe fusion surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female with no racial or ethnic restrictions;
- •18 to 75 years old;
- •Have a bunionectomy or toe fusion surgery scheduled;
- •must be able to read, understand, and sign consent form;
- •generally healthy.
排除标准
- •Chronic neurologic conditions, e.g., Parkinson's
- •pregnancy;
- •opioids use 60 mg/day oral morphine milligram equivalent.;
- •use of anticoagulants (low dose ASA allowed);
- •history of gastric ulcer; renal insufficiency or congestive heart failure,
- •contraindication to study medication as determined by surgeon
- •Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk
- •In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
- •Diagnosis of psychological diseases, such as major depression; bipolar disorder.
研究组 & 干预措施
Carbidopa-Levodopa (100mg/25mg) + Naproxen (250mg)
The study drug, Carbidopa-Levodopa, is an FDA-approved medicine traditionally used for the treatment of Parkinson's disease. The study drug will be used for an un-approved or un-labeled use: potentially managing pain in post-surgical patients. Carbidopa/Levodopa is an artificially made version of a naturally occurring hormone that helps regulate brain activity (Levodopa), combined with an artificially made version of a naturally occurring molecule that inhibits the breakdown of Levodopa (Carbidopa).
Naproxen (250mg): Participants will receive one capsule TID, throughout the 5 days of the treatment period. Naproxen will be prescribed for active and control group.
干预措施: Naproxen (Drug)
Placebo + Naproxen (250mg)
Placebo:Participants will receive 1 the capsules on a three-times a day schedule for 5 days. A placebo looks like the study drug but is an inactive substance that has no medication. Researchers use a placebo to see if the study drug works better or is safer than not taking anything.
Naproxen (250mg): Participants will receive one capsule TID, throughout the 5 days of the treatment period. Naproxen will be prescribed for active and control group.
干预措施: Naproxen (Drug)
结局指标
主要结局
Post-Surgical Pain using Numeric Rating Scale (NRS)
时间窗: 1 and 4 weeks
The primary endpoint will be the severity of pain measured by mean post surgical pain from surgery to end of intervention (\~1 week) and end of the study, as indexed by a NRS. The NRS pain scale is a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine''). Mean pain during treatment will be compared between intervention groups.
次要结局
- Adverse Events(1 and 4 weeks)
- Patient Global Impression of Change (PGIC)(1 and 4 weeks)
研究者
Apkar Apkarian
Director Center for Translational Pain Research; Director Center of Excellence for Chronic Pain and Drug Abuse Research; Professor of Neuroscience; Anesthesia, and PM&R
Northwestern University