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Non-opioid Pain Management for Postoperative Pain

Phase 2
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled for bunionectomy or toe fusion surgery
Aged 18 to 75 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 4 weeks
Awards & highlights

Study Summary

This trial will test if a drug combo can reduce post-surgery pain for women better than a placebo.

Who is the study for?
This trial is for healthy females aged 18 to 75 who are scheduled for bunionectomy or toe fusion surgery. Participants must be able to understand and sign a consent form. Those pregnant, with gastric ulcers, chronic neurological conditions like Parkinson's, on high opioid doses or anticoagulants (except low dose ASA), or with renal insufficiency or heart failure cannot join.Check my eligibility
What is being tested?
The study tests if Carbidopa/Levodopa combined with Naproxen reduces pain after foot surgery better than a placebo with Naproxen. Pain levels will be compared at different times post-surgery: after 24 hours, 48 hours, and five days.See study design
What are the potential side effects?
Possible side effects include digestive issues such as stomach pain and ulcers from Naproxen; dizziness, headache, confusion from Carbidopa/Levodopa; plus the general risks of taking medications like allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a scheduled bunionectomy or toe fusion surgery.
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You must be between 18 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-Surgical Pain using Numeric Rating Scale (NRS)
Secondary outcome measures
Adverse Events
Patient Global Impression of Change (PGIC)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Carbidopa-Levodopa (100mg/25mg) + Naproxen (250mg)Experimental Treatment2 Interventions
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 II: Placebo + Naproxen (250mg)Placebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naproxen
2019
Completed Phase 4
~31530

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,574 Previous Clinical Trials
909,593 Total Patients Enrolled
2 Trials studying Acute Pain
30 Patients Enrolled for Acute Pain
Northwestern Medical GroupOTHER
1 Previous Clinical Trials
226 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,678 Previous Clinical Trials
6,909,736 Total Patients Enrolled
2 Trials studying Acute Pain
106 Patients Enrolled for Acute Pain

Media Library

Carbidopa-Levodopa (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05087914 — Phase 2
Acute Pain Research Study Groups: Placebo + Naproxen (250mg), Carbidopa-Levodopa (100mg/25mg) + Naproxen (250mg)
Acute Pain Clinical Trial 2023: Carbidopa-Levodopa Highlights & Side Effects. Trial Name: NCT05087914 — Phase 2
Carbidopa-Levodopa (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05087914 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what reasons is Naproxen typically given to patients?

"Naproxen is not only effective in managing pain, but also seasonal allergic rhinitis, muscle spasms, and juvenile rheumatoid arthritis."

Answered by AI

Is Naproxen a new medication?

"At this time, there are 27 clinical trials for Naproxen that are currently active. 10 of these trials are in Phase 3. While some of the trials for Naproxen are based in Evanston, Illinois, there are a total of 308 locations running trials for Naproxen."

Answered by AI

How many patients are participating in this clinical trial?

"That is correct, the online information hosted on clinicaltrials.gov does show that this study is looking for volunteers at the moment. This particular trial was first made public on November 1st, 2021 and was last edited two weeks ago on the 16th of November. They are hoping to find 60 individuals total from just one location."

Answered by AI

Are people still being signed up for this experiment?

"This clinical trial, as listed on clinicaltrials.gov, is currently looking for patients. The listing was first posted on November 1st 2021 and last updated on November 16th 2021."

Answered by AI

Is this research only being conducted with people who are 25 years or younger?

"The age limit for this clinical trial is 75 years old, with a minimum age of 18 years required for study participation."

Answered by AI

Is Naproxen known to cause any serious side effects?

"While there is some data suggesting that Naproxen is safe, it did not receive a perfect score because Phase 2 trials have yet to produce clinical evidence of the medication's efficacy."

Answered by AI

Could I be a candidate for this research project?

"We are looking for 60 individuals, both male and female, who currently suffer from acute pain and meet the following criteria: between 18-75 years old; no racial or ethnic restrictions; have a bunionectomy or toe fusion surgery scheduled; able to read, understand, and sign a consent form; generally healthy."

Answered by AI
~18 spots leftby Mar 2025