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Non-opioid Pain Management for Postoperative Pain
Phase 2
Waitlist Available
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 and 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 4 weeks
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
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,601 Previous Clinical Trials
915,664 Total Patients Enrolled
2 Trials studying Acute Pain
40 Patients Enrolled for Acute Pain
Northwestern Medical GroupOTHER
1 Previous Clinical Trials
226 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,227 Total Patients Enrolled
2 Trials studying Acute Pain
106 Patients Enrolled for Acute Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a stomach ulcer in the past.You have been diagnosed with major depression or bipolar disorder.You have a scheduled bunionectomy or toe fusion surgery.You have long-term neurological conditions like Parkinson's disease.You take more than 60 mg of oral morphine (or its equivalent) per day.You are taking blood thinners, except for low-dose aspirin.You have kidney problems or heart failure.You must be between 18 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo + Naproxen (250mg)
- Group 2: Carbidopa-Levodopa (100mg/25mg) + Naproxen (250mg)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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