Intraosseous Morphine in Primary TKA

Study Overview
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Brief Summary
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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.

Official Title
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Intraosseous Morphine Administration During Primary Total Knee Arthroplasty: A Randomized Clinical Trial

Conditions
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Knee Disease, Arthritis Knee, Pain, Acute

Intervention / Treatment
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* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Patient receives an intraosseous injection of antibiotics into the tibia as per the standard of care for primary total knee arthroplasty under the study providers. | |
| Experimental: Intarosseous Morphine<br>Patient receives an intraosseous injection of antibiotics + 10mg of morphine into the tibia during their total knee arthroplasty. | Drug: Morphine<br>* 10mg of Morphine delivered Intraosseously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Pain | Patient will fill out Visual Analog Scale pain scores three times a day for 14 days (day 1 as day of surgery) post-op in a pain journal. Levels will be compared between study groups. A higher score indicates a higher self-perceived level of pain and a lower score indicates a lower perceived level of pain for the patient. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 and IL-8 Inflammatory markers | Levels of IL-6, IL-8 in pg/ml | pre op, 15 minutes post-tourniquet release, and 10 hours post intraosseous injection. | 
| CD11a, CD11b, CD11c, and CD18 inflammatory markers | Levels of CD11a, CD11b, and CD18 (raw number) | pre op, 15 minutes post-tourniquet release, and 10 hours post intraosseous injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraosseous, Total knee arthroplasty, Morphine