Novel Non-opioid Post-surgical Pain Treatment in Females

Northwestern University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Acute Pain Bunionectomy Toe Fusion

Interventions

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.

NaproxenDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 and 4 weeks

Secondary Outcomes

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.

Time frame: 1 and 4 weeks

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.

Time frame: 1 and 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.