Clinical trial NCT04388111: Intraosseous Morphine in Primary TKA
Official title: Intraosseous Morphine Administration During Primary Total Knee Arthroplasty: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Disease
Arthritis Knee
Pain, Acute
Keywords: Intraosseous
Total knee arthroplasty
Morphine
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Post-operative Pain
timeFrame: 14 days
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Pre-operative
timeFrame: preoperative
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative
timeFrame: two week postoperatively
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative
timeFrame: 8 weeks postoperatively
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
References: