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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
100
10 mg morphine in 10 mL normal saline
500 mg Vancomycin in 100 mL of normal saline
Carilion Clinic
Roanoke, Virginia, United States
Postoperative pain levels
Pain scores on a scale of 0-10 with 0 meaning no pain and 10 being the worst pain possible
Time frame: 14 days postoperatively
Postoperative pain medication consumption
How much pain medication patients consumed following surgery. Measured in morphine milliequivalents (MME).
Time frame: 14 days postoperatively
Number of patients with postoperative nausea and vomiting
Number of patients with postoperative nausea and vomiting episodes within 14 days of surgery
Time frame: 14 days postoperatively
Patient reported outcomes (KOOS)
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.
Time frame: 1 month preoperative to 6 weeks postoperative
Patient reported outcomes (PROMIS)
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.
Time frame: 1 month preoperative to 6 weeks postoperative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.