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NCT Number: NCT04388111

Intraosseous Morphine in Primary TKA

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.

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Key information

Conditions

Knee Disease Acute Pain Arthritis Knee Neurologic Manifestations Pain Pain, Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Morphine

Drug

10mg of Morphine delivered Intraosseously

Primary outcomes

  1. Post-operative Pain

    Time frame: 14 days

    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. "0" representing no pain at all on the scale and "10" representing the highest pain imaginable. Scores are reported 3 times a day per day and averaged for that day. All of these scores were then averaged for the 14 day period and reported below.

Secondary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Pre-operative

    Time frame: preoperative

    KOOS Jr Score patient reported outcome measure. Scale is from 0 to 100 with a 0 being total knee disability and 100 being perfect knee health.

  2. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative

    Time frame: two week postoperatively

    KOOS Jr Score patient reported outcome measure. Scale is from 0 to 100 with a 0 being total knee disability and 100 being perfect knee health. Reported two-weeks post-operative.

  3. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative

    Time frame: 8 weeks postoperatively

    KOOS Jr Score patient reported outcome measure. Scale is from 0 to 100 with a 0 being total knee disability and 100 being perfect knee health. Reported 8 weeks post-operative.

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 14, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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