Intraosseous Morphine in Primary TKA

The Methodist Hospital Research Institute65 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Knee Disease Arthritis Knee Pain, Acute

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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. "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.

Time frame: 14 days

Secondary Outcomes

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

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.

Time frame: preoperative

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

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.

Time frame: two week postoperatively

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

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.

Time frame: 8 weeks postoperatively