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Help Us Advance Postoperative Pain Management Options
Our research study is evaluating how effective a potential new non-opioid pain medication is at managing postoperative pain following inguinal hernia repair surgery.Those who qualify and choose to participate could receive the surgery at no cost and earn up to $1,500 in 5 visits over 45 days.
About the Study:
This study is evaluating the investigational drug Meloxicam (or MR-107A-02) to determine if it is safe and effective in the treatment of pain relief following an inguinal hernia repair surgery. Meloxicam is a non-steroidal anti-inflammatory drug. It is not considered addictive and it is not a narcotic or opioid.
If you continue to qualify and choose to participate after your surgical procedure, you will be randomly assigned to one of three study groups. You will have a 40% chance of receiving the study drug, a 20% chance of receiving Tramadol (active control), and a 40% chance of receiving a placebo. A placebo is an inactive substance that looks like the study drug but contains no active ingredient. The study drug will be administered every 6 hours for the following 42 hours after your surgical procedure. Once discharged, you will take the study drug twice a day. If you feel the need for additional pain medication, 2 steps of rescue medication will also be available.
The study will consist of 5 visits over 45 days and will include the inguinal hernia repair surgery and a minimum 48 hour in-patient stay.
There is no cost to participate in the study.
Why Should I Participate?
Those who qualify and choose to participate could receive:
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Their inguinal hernia repair surgery at no cost
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Access to a potential new pain management medication at no cost
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Access to our dedicated team of board-certified surgeons, physicians and research team at no cost
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Compensation up to $1,500 for 5 visits over 45 days
Study Criteria
To qualify to participate you must:
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Be aged 18 years or older
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Require an open inguinal hernia repair surgery
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Have a BMI less than 40
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NOT have had a prior inguinal hernia repair surgery in the last 2 years
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NOT have a known hypertensivity to aspirin or other NSAIDs
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NOT have a history of drug or alcohol abuse
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Additional criteria applies
What is a research study or clinical trial?
A research study or clinical trial is the process a potential new drug, device, procedure, or process goes through to prove that it is safe, tolerable and effective for the condition it is being studied for. Research studies are the only way to advance medicine for future generations.
Who can participate in a research study?
Each study has its own set of inclusion and exclusion criteria that a participant must meet before they are allowed to participate in a study. Patients from all backgrounds and walks of life are encouraged to participate.
What is Informed Consent?
Every participant in every research study must go through the informed consent process. During this, the trial doctor and research team go over what will happen in the study, what treatments you might get, how long the trial is expected to last, what happens during visits, the potential risks and benefits, and many other important facts about the study. Participants may withdraw their consent and discontinue the study at any time for any reason.
What is a Placebo?
A placebo looks like a treatment but does not have any active medicine in it. Researchers use placebos to help make sure any changes in the participants’ health are actually caused by the study treatment. You do not get to choose if you get the study treatment or the placebo, and you may not know if you get the placebo until after the study. Not all research studies use a placebo.
Why is Diversity Important?
If studies do not include diverse participants, we cannot know if treatments work for everyone who needs them. Studies only tell researchers how something works for the participants of that study, and they may not work the same in people of different races, ethnicities, ages, or sexes.
How am I Protected?
All research studies must follow federal laws and ethical guidelines, including HIPAA. Studies must also be approved by an expert group called an institutional review board (IRB) that helps make sure the trial is fair and as safe as possible, and that any risks to the participants are worth the potential benefits.