Trial Comparing a Multi-Modal Pain Protocol With and Without Opioids Following Total Joint Arthroplasty

• Status: Completed
• Trial end date: 2020-07-28
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: Ambit Biosciences Corporation; Kern Medical Center
• Treatments: Analgesics, Opioid; Oxycodone

Criteria

Inclusion Criteria:

1. Age > 18 and < 90 years.

2. Willing to participate in the study and competent to provide informed consent.

3. Willing to comply with protocol procedures.

4. Has an underlying diagnosis of osteoarthritis indicated for knee arthroplasty.

Exclusion Criteria:

1. A diagnosis of renal or liver disease

2. If a patient has a contraindication to receiving a spinal anesthetic or pain catheter

3. The patient must not have taken any narcotic medications during the 3 months leading up to the surgery

4. The patient must not be allergic or intolerant to a medication used in the multi-modal pain pathway

5. Revision hip or knee arthroplasty

6. If a patient is being treated under worker's compensation

7. If a patient has diabetes

8. Unable to take Aspirin 325 mg twice daily for deep venous thromboprophylaxis