Intraosseous Morphine in Primary TKA
Primary Purpose
Knee Disease, Arthritis Knee, Pain, Acute
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Knee Disease focused on measuring Intraosseous, Total knee arthroplasty, 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.
Sites / Locations
- Houston Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Intarosseous Morphine
Arm Description
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.
Patient receives an intraosseous injection of antibiotics + 10mg of morphine into the tibia during their total knee arthroplasty.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
IL-6 and IL-8 Inflammatory markers
Levels of IL-6, IL-8 in pg/ml
CD11a, CD11b, CD11c, and CD18 inflammatory markers
Levels of CD11a, CD11b, and CD18 (raw number)
Full Information
NCT ID
NCT04388111
First Posted
May 11, 2020
Last Updated
July 2, 2021
Sponsor
The Methodist Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04388111
Brief Title
Intraosseous Morphine in Primary TKA
Official Title
Intraosseous Morphine Administration During Primary Total Knee Arthroplasty: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 5, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Methodist Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Disease, Arthritis Knee, Pain, Acute
Keywords
Intraosseous, Total knee arthroplasty, Morphine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
Patient, provider, and laboratory technicians are blinded to the patient's study group. Only the research coordinator and necessary OR support staff are aware of the patient's study group.
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intarosseous Morphine
Arm Type
Experimental
Arm Description
Patient receives an intraosseous injection of antibiotics + 10mg of morphine into the tibia during their total knee arthroplasty.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
10mg of Morphine delivered Intraosseously
Primary Outcome Measure Information:
Title
Post-operative Pain
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
IL-6 and IL-8 Inflammatory markers
Description
Levels of IL-6, IL-8 in pg/ml
Time Frame
pre op, 15 minutes post-tourniquet release, and 10 hours post intraosseous injection.
Title
CD11a, CD11b, CD11c, and CD18 inflammatory markers
Description
Levels of CD11a, CD11b, and CD18 (raw number)
Time Frame
pre op, 15 minutes post-tourniquet release, and 10 hours post intraosseous injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
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Intraosseous Morphine in Primary TKA
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