Arthritis Knee, Knee Disease, Pain, Acute
Conditions
Keywords
Intraosseous, Total knee arthroplasty, Morphine
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.
Interventions
DRUGMorphine
10mg of Morphine delivered Intraosseously
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Pre-operative | 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. |
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative | 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. |
Countries
United States
Participant flow
Recruitment details
Recruited at hospital from 5/5/2020 through 4/1/2021
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Intarosseous Morphine Patient receives an intraosseous injection of antibiotics + 10mg of morphine into the tibia during their total knee arthroplasty.
Morphine: 10mg of Morphine delivered Intraosseously | 24 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 5 | 3 |
| Overall Study | Protocol Violation | 2 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Control Group | Intarosseous Morphine | Total |
|---|---|---|---|
| Age, Continuous | 65.06 years STANDARD_DEVIATION 6.37 | 65.20 years STANDARD_DEVIATION 8.01 | 65.13 years STANDARD_DEVIATION 7.16 |
| BMI | 30.58 KG/m^2 STANDARD_DEVIATION 3.89 | 31.36 KG/m^2 STANDARD_DEVIATION 5.09 | 30.97 KG/m^2 STANDARD_DEVIATION 4.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 24 Participants | 24 Participants | 48 Participants |
| Sex: Female, Male Female | 11 Participants | 15 Participants | 26 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 22 Participants |
| Weight (kg) | 96.03 KG STANDARD_DEVIATION 21.74 | 88.13 KG STANDARD_DEVIATION 15.99 | 92.08 KG STANDARD_DEVIATION 19.29 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 1 / 24 | 1 / 24 |
Outcome results
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. 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Post-operative Pain | 4.29 visual analog pain scale | Standard Deviation 0.39 |
| Intarosseous Morphine | Post-operative Pain | 3.57 visual analog pain scale | Standard Deviation 0.37 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Pre-operative | 52.0 KOOS Jr. Score | Standard Error 2 |
| Intarosseous Morphine | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Pre-operative | 51.4 KOOS Jr. Score | Standard Error 2.1 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative | 57.1 KOOS Jr. Score | Standard Error 2 |
| Intarosseous Morphine | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative | 62.2 KOOS Jr. Score | Standard Error 2.1 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative | 64.0 KOOS Jr. Score | Standard Error 2.2 |
| Intarosseous Morphine | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative | 71.5 KOOS Jr. Score | Standard Error 2.3 |