Clinical trial NCT05087914: Novel Non-opioid Post-surgical Pain Treatment in Females
Official title: Novel Non-opioid Post-surgical Pain Treatment in Females
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Pain
Bunionectomy
Toe Fusion
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Northwestern Medical Group
name: National Institutes of Health (NIH)
First posted: 2021-10-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Post-Surgical Pain using Numeric Rating Scale (NRS)
timeFrame: 1 and 4 weeks
Secondary outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: 1 and 4 weeks
measure: Adverse Events
timeFrame: 1 and 4 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
References: