Novel Non-opioid Post-surgical Pain Treatment in Females

NCT ID: NCT05087914

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2024-01-30

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.

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.

Conditions

Acute Pain; Bunionectomy; Toe Fusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Carbidopa-Levodopa (100mg/25mg):

Intervention Type: 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.

Naproxen

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Naproxen

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Sinemet; Parcopa; Rytary; Aleve; Anaprox; Naprosyn; Naprelan; Menstridol

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern Medical Group

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Apkar Apkarian

Director Center for Translational Pain Research; Director Center of Excellence for Chronic Pain and Drug Abuse Research; Professor of Neuroscience; Anesthesia, and PM&R

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00215128

Identifier Type: -

Identifier Source: org_study_id