Not provided
Not provided
Not provided
Not provided
Not provided
Study was not started, therefore recruitment did not happen
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Northwestern Medical Group | OTHER |
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbidopa-Levodopa (100mg/25mg) + Naproxen (250mg) | Experimental | 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. |
|
| Placebo + Naproxen (250mg) | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbidopa-Levodopa (100mg/25mg): | Drug | Participants will take 2 capsules (one containing naproxen, and the other containing either placebo or carbidopa/levodopa) 3 times per day (TID) for 5 days, the first dose is given right after the surgical procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Surgical Pain using Numeric Rating Scale (NRS) | 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. | 1 and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGIC) | This questionnaire reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. PGIC score will be compared between intervention groups. | 1 and 4 weeks |
| Adverse Events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
female (biological sex) with no racial or ethnic restrictions
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Naproxen | Drug | Participants will take 2 capsules (one containing naproxen, and the other containing either placebo or carbidopa/levodopa) 3 times per day (TID) for 5 days, the first dose is given right after the surgical procedure. |
|
|
Participants will be query for possible adverse events during the intervention period (~1 weeks). Incidence of adverse events will be reported every visit.The frequency and severity of adverse effects will be compared between each intervention group. |
| 1 and 4 weeks |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |