Trial Comparing a Multi-Modal Pain Protocol With and Without Opioids Following Total Joint Arthroplasty
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Total Knee Arthroplasty
In brief
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 inclusion of opioid medications. This study will be performed in a randomized, double-blinded, placebo-controlled fashion in patients undergoing primary total knee or total hip arthroplasty. Investigators hypothesize that the opioid devoid pathway will show equivalent pain scores to the pathway that includes opioids while also having less constipation, nausea, and vomiting following surgery. If successful, this would create a dramatic decrease in opioid consumption following orthopedic surgery while still providing appropriate pain relief to patients.
Key facts
- Study ID
- NCT03845881
- Run by
- Mayo Clinic
- People needed
- 45
- Starts
- 2019-04-10
- Expected to finish
- 2020-07-28
- Last updated by the study team
- 2020-07-30
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Mayo Clinic in Florida — Jacksonville, Florida, United States
Full record on ClinicalTrials.gov
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