Intraosseous Morphine in Primary TKA

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Arthritis Knee; Knee Disease
• Intervention / Treatment: Drug: Morphine

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control Group; 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; Patient receives an intraosseous injection of antibiotics + 10mg of morphine into the tibia during their total knee arthroplasty.	Drug: Morphine; 10mg of Morphine delivered Intraosseously

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 5, 2020
• Primary Completion (ACTUAL): April 30, 2021
• Study Completion (ACTUAL): May 31, 2021

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (ACTUAL): May 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Morphine; Total knee arthroplasty; Intraosseous
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: Pro000023481

Drug and device information, study documents

• 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