Overview

The Mayo Clinic is hosting a clinical trial that attempts to gauge the effectiveness of orthopaedic surgery with a new model. The main advantage of the new model is the lack of opioids to relieve pain after surgery. Additionally, it will also decrease symptoms of nausea, vomiting, and constipation. Researchers will assess pain levels, opioid levels, side effects, and length of hospitalization.

Study Information

This is a study where participants are assigned to two groups at random. Members of both groups will not know in which they are placed. One group will be given oxycodone, an opioid pain medication, and the other group will not. The non-opioid group will be given a placebo.

Inclusion Criteria

1. All sexes ages 18 to 90 years old
2. Patients must be willing to participate and able to provide informed consent.
3. Everyone must adhere to procedures of study
4. An underlying diagnosis of osteoarthritis for knee arthroplasty must be possessed

Exclusion Criteria

1. Renal or liver disease diagnosis
2. Patients who have any issues receiving a spinal anesthetic or pain catheter
3. Those who have taken any narcotic medications in the 3 months prior to surgery
4. Patients who are allergic to or unable to tolerate any medication used in the clinical trial
5. Revision hip or knee arthroplasty
6. Patients who are receiving surgery and aftercare under worker’s compensation
7. Patients with diabetes
8. Not able to take 325 milligrams of aspirin two times per day for deep venous thromboprophylaxis

Locations

You may participate in this clinical trial at the Mayo Clinic in Florida in Jacksonville, Florida, United States, 32224. If you have any questions or concerns, please contact Lori Chase at 312-238-7503 or at wdee@sralab.org.

Sponsors/Collaborators

This study is sponsored by the Mayo Clinic and collaborated by Ambit Biosciences Corporation and Kern Medical Center. Benjamin Wilke, MD of the Mayo Clinic will be the Principal Investigator.