Intraosseous Morphine Injection, Knee Osteoarthritis, Primary Total Knee Arthroplasty
Conditions
Brief summary
Study investigators propose to investigate if a bony injection of pain medication during a knee replacement will help pain levels following primary knee replacement surgery. To investigate this, 86 patients will be enrolled. Half of the patients will receive a bony injection of antibiotics with morphine (pain medication) while the other half will receive a bony injection of antibiotics with placebo (no pain medication). Following surgery, patient pain levels and pain medication consumption will be measured. The injection is intraosseous meaning in the bone. The needle pierces the bone and the medication is injected into the bone. The site of injection is on the anterior (front) of the upper portion of the tibia. The medications are Vancomycin (antibiotic) and Morphine (pain medication) which are mixed in separate syringes and then injected. Intraosseous vancomycin is standard of care while intraosseous vancomycin with morphine is also standard of care, depending on operating surgeon.
Interventions
DRUGMorphine
10 mg morphine in 10 mL normal saline
DRUGVancomycin
500 mg Vancomycin in 100 mL of normal saline
Sponsors
Carilion Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Patients, care team, and research team are all blinded to their respective group until the study is concluded.
Intervention model description
43 patients receiving placebo. 43 patients receiving experimental.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. 18-100 years old 2. Primary total knee arthroplasty 3. Participants must be able to consent for themselves 4. Capable and comfortable with text messaging
Exclusion criteria
1. Non-primary total knee arthroplasty 2. Intraoperative or postoperative deviation from standard of care 3. Post-traumatic surgical indication 4. Post-infectious surgical indication 5. Chronic narcotic use or history of narcotic addiction 6. Allergy to vancomycin 7. Allergy to morphine 8. Inability to receive spinal anesthesia 9. Inability to receive intraoperative adductor canal block 10. Inability to provide informed consent for the study 11. Inability to speak English fluently
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain levels | 14 days postoperatively | Pain scores on a scale of 0-10 with 0 meaning no pain and 10 being the worst pain possible |
| Postoperative pain medication consumption | 14 days postoperatively | How much pain medication patients consumed following surgery. Measured in morphine milliequivalents (MME). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with postoperative nausea and vomiting | 14 days postoperatively | Number of patients with postoperative nausea and vomiting episodes within 14 days of surgery |
| Patient reported outcomes (KOOS) | 1 month preoperative to 6 weeks postoperative | Patient reported outcomes preoperative and postoperative. Preoperative measurement compared to 6 weeks postoperative. KOOS is measured 0-100 with 0 representing total knee disability and 100 representing a perfect knee. |
| Patient reported outcomes (PROMIS) | 1 month preoperative to 6 weeks postoperative | Patient reported outcomes preoperative and postoperative. Preoperative measurement compared to 6 weeks postoperative. Range is 20-80 with higher being better. The mean is 50 with the standard deviation being 10. |
Countries
United States
Outcome results
None listed