Novel Non-opioid Post-surgical Pain Treatment in Females

Acute Pain Clinical Trial

Official title:

Novel Non-opioid Post-surgical Pain Treatment in Females

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05087914
• Other study ID #: STU00215128
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 1, 2021
• Est. completion date: January 30, 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn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.

Related Conditions & MeSH terms

• Acute Pain
• Bunionectomy
• Pain, Postoperative

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	National Institutes of Health (NIH), Northwestern Medical Group

Country where clinical trial is conducted

United States, 

Outcome

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