Clinical trial NCT06716749: Effectiveness of Adding Morphine to Intraosseous Vancomycin for Pain Control in Total Knee Arthroplasty
Official title: Effectiveness of Adding Morphine to Intraosseous Vancomycin for Pain Control in Total Knee Arthroplasty: A Double-Blind, Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Primary Total Knee Arthroplasty
Intraosseous Morphine Injection
Knee Osteoarthritis
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 43 patients receiving placebo. 43 patients receiving experimental.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain levels
timeFrame: 14 days postoperatively
measure: Postoperative pain medication consumption
timeFrame: 14 days postoperatively
Secondary outcomes:
measure: Number of patients with postoperative nausea and vomiting
timeFrame: 14 days postoperatively
measure: Patient reported outcomes (KOOS)
timeFrame: 1 month preoperative to 6 weeks postoperative
measure: Patient reported outcomes (PROMIS)
timeFrame: 1 month preoperative to 6 weeks postoperative
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Joseph T Moskal, MD
role: PRINCIPAL_INVESTIGATOR
References: