Novel Non-opioid Post-surgical Pain Treatment in Females

• Status: Not yet recruiting
• Trial end date: 2023-01-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborators: National Institutes of Health (NIH); Northwestern Medical Group
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Levodopa; Naproxen

Criteria

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.