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

Effectiveness of Adding Morphine to Intraosseous Vancomycin for Pain Control in Total Knee Arthroplasty: A Double-Blind, Randomized Trial

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 Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Primary Total Knee Arthroplasty; Intraosseous Morphine Injection
• Intervention / Treatment: Drug: Vancomycin; Drug: Morphine

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Carilion Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control (Intraosseous vancomycin with no morphine); 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.	Drug: Vancomycin; 500 mg Vancomycin in 100 mL of normal saline; Other Names: IO antibiotic
Experimental: Experimental (Intraosseous vancomycin with 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.	Drug: Vancomycin; 500 mg Vancomycin in 100 mL of normal saline; Other Names: IO antibiotic; Drug: Morphine; 10 mg morphine in 10 mL normal saline; Other Names: IO pain medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain levels	Pain scores on a scale of 0-10 with 0 meaning no pain and 10 being the worst pain possible	14 days postoperatively
Postoperative pain medication consumption	How much pain medication patients consumed following surgery. Measured in morphine milliequivalents (MME).	14 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with postoperative nausea and vomiting	Number of patients with postoperative nausea and vomiting episodes within 14 days of surgery	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.	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.	1 month preoperative to 6 weeks postoperative

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Investigators: Principal Investigator: Joseph T Moskal, MD, Carilion Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): May 15, 2025
• Study Completion (Actual): June 2, 2025

Study Registration Dates

• First Submitted: November 17, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Peptides; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Carbohydrates; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Glycoconjugates; Glycopeptides; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Morphine; Vancomycin
• Other Study ID Numbers: IRB-24-1831

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes