Novel Non-opioid Post-surgical Pain Treatment in Females

Phase 2

Withdrawn

• Conditions: Acute Pain; Toe Fusion; Bunionectomy
• Interventions: Drug: Naproxen

• Registration Number: NCT05087914
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-10-21
• Study Start: 2021-11-01
• Primary Completion: 2023-12-30
• Study Completion: 2024-01-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbidopa-Levodopa (100mg/25mg) + Naproxen (250mg)	Naproxen	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.
Placebo + Naproxen (250mg)	Naproxen	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States