Intraosseous Morphine in Primary TKA

• Status: Completed
• Trial end date: 2021-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The research team wants to investigate if an intraosseous injection (directly into the bone marrow) of morphine during primary total knee replacement helps with post-operative pain following primary total knee replacement surgery. For this study patients will either be randomized into one of two groups: Group 1: Receives an intraosseous injection of morphine (mixed with standard antibiotics) during their primary total knee replacement or Group 2: Serves as the control group and only receives an intraosseous injection of antibioitics during their total knee replacement. The research team will have patients fill out a symptom journal for two weeks following their surgery to measure pain levels and pain medication consumed throughout the day as well as nausea and other symptoms. Additionally, the research team will take blood samples both intraoperatively and post-operatively (10 hours post-op) to measure the level of inflammatory markers as well as morphine.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Methodist Hospital Research Institute; The Methodist Hospital System
• Treatments: Morphine

Criteria

Inclusion Criteria:

• Patient gives informed consent to participate in the study

• Patient is undergoing a primary total knee arthroplasty.

• Age > 18 and <80 years old.

Exclusion Criteria:

• Patient lacks the capacity to consent to the research project (study will not utilize LAR signatures during the informed consent process)

• Weigh < 100 pounds

• BMI > 35

• Pregnancy or suspected pregnancy

• Past medical history of opioid addiction.

• Established hypersensitivity (ie allergy) to morphine.

• Acute or chronic liver disease for example cirrhosis.

• Use of any narcotics 5 days before surgery (opioids, hydrocodone, morphine, hydromorphone, fentanyl, etc).

• Undergoing bilateral total knee replacement, revision total knee arthroplasty, or any additional procedure outside of a primary total knee arthroplasty.

• Unable to get general and spinal anesthesia.