Status:
COMPLETED
Trial Comparing a Multi-Modal Pain Protocol With and Without Opioids Following Total Joint Arthroplasty
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Ambit Biosciences Corporation
Kern Medical Center
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
18-89 years
Phase:
EARLY_PHASE1
Brief Summary
To help curb the use of opioid medications following orthopedic surgery investigators have developed a new multi-modal pain pathway. Investigators aim to compare this regimen with and without the incl...
Detailed Description
* Aim 1 will be to compare the postoperative pain levels both in the hospital setting as well as daily for two weeks following discharge between patients in the opioid treatment group and those in the...
Eligibility Criteria
Inclusion
- Age \> 18 and \< 90 years.
- Willing to participate in the study and competent to provide informed consent.
- Willing to comply with protocol procedures.
- Has an underlying diagnosis of osteoarthritis indicated for knee arthroplasty.
Exclusion
- A diagnosis of renal or liver disease
- If a patient has a contraindication to receiving a spinal anesthetic or pain catheter
- The patient must not have taken any narcotic medications during the 3 months leading up to the surgery
- The patient must not be allergic or intolerant to a medication used in the multi-modal pain pathway
- Revision hip or knee arthroplasty
- If a patient is being treated under worker's compensation
- If a patient has diabetes
- Unable to take Aspirin 325 mg twice daily for deep venous thromboprophylaxis
Key Trial Info
Start Date :
April 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03845881
Start Date
April 10 2019
End Date
July 28 2020
Last Update
July 30 2020
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224