Intraosseous Morphine in Primary TKA

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04388111
• Other study ID #: Pro000023481
• Status: Completed
• Phase: Phase 4
• Start date: May 5, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: July 2021
• Source: The Methodist Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Arthritis Knee
• Knee Disease
• Pain, Acute

Intervention

Drug:
• Morphine
10mg of Morphine delivered Intraosseously

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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