Acute Pain Clinical Trial
Official title:
Novel Non-opioid Post-surgical Pain Treatment in Females
Verified date | March 2024 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 30, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University Feinberg School of Medicine | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | National Institutes of Health (NIH), Northwestern Medical Group |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Adverse Events | 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 |
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