Effectiveness of Adding Morphine to Intraosseous Vancomycin for Pain Control in Total Knee Arthroplasty

Carilion Clinic

Status and phase: Completed; Phase 2

Conditions: Intraosseous Morphine Injection; Primary Total Knee Arthroplasty; Knee Osteoarthritis

Treatments: Drug: Vancomycin; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT06716749

IRB-24-1831

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Control (Intraosseous vancomycin with no morphine)

Placebo Comparator group

Description:

Control patients will receive 500 mg of vancomycin in 100 mL of normal saline + 10 mL of normal saline (placebo). Both with be injected intraosseously in the tibia.

Treatment:

Drug: Vancomycin

Experimental (Intraosseous vancomycin with morphine)

Experimental group

Description:

Control patients will receive 500 mg of vancomycin in 100 mL of normal saline + 10 mg of morphine in 10 mL of normal saline. Both with be injected intraosseously in the tibia.

Treatment:

Drug: Morphine

Drug: Vancomycin