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

Phase 2

Recruiting

• Conditions: Primary Total Knee Arthroplasty; Intraosseous Morphine Injection; Knee Osteoarthritis
• Interventions: Drug: Vancomycin; Drug: Morphine

• Registration Number: NCT06716749
• Lead Sponsor: Carilion Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-17
• Study Start: 2024-12-01
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (Intraosseous vancomycin with no morphine)	Vancomycin	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.
Experimental (Intraosseous vancomycin with morphine)	Morphine	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.
Experimental (Intraosseous vancomycin with morphine)	Vancomycin	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Carilion Clinic; 🇺🇸 Roanoke, Virginia, United States