Novel Non-opioid Post-surgical Pain Treatment in Females
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Carbidopa-Levodopa (100mg/25mg):
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.
Other Names:
Drug: Naproxen
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.
Other Names:
|
| Placebo Comparator: 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. |
Drug: Naproxen
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Post-Surgical Pain using Numeric Rating Scale (NRS) [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.
Secondary Outcome Measures
- Patient Global Impression of Change (PGIC) [1 and 4 weeks]
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.
- Adverse Events [1 and 4 weeks]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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female with no racial or ethnic restrictions;
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18 to 75 years old;
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Have a bunionectomy or toe fusion surgery scheduled;
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must be able to read, understand, and sign consent form;
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generally healthy.
Exclusion Criteria:
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Chronic neurologic conditions, e.g., Parkinson's
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pregnancy;
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opioids use 60 mg/day oral morphine milligram equivalent.;
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use of anticoagulants (low dose ASA allowed);
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history of gastric ulcer; renal insufficiency or congestive heart failure,
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contraindication to study medication as determined by surgeon
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Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk
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In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
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Diagnosis of psychological diseases, such as major depression; bipolar disorder.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern University Feinberg School of Medicine | Chicago | Illinois | United States | 60611 |
| 2 | Northwestern University Feinberg School of Medicine | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
- Northwestern Medical Group
- National Institutes of Health (NIH)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU00215128