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

NCT06716749 | Completed Phase 2 FDA Drug

• 1 other identifier: IRB-24-1831
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Total Knee Arthroplasty; Intraosseous Morphine Injection; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of patients with postoperative nausea and vomiting

  14 days postoperatively

• Patient reported outcomes (KOOS)

  1 month preoperative to 6 weeks postoperative

• Patient reported outcomes (PROMIS)

  1 month preoperative to 6 weeks postoperative

Study Arms (2)

Control (Intraosseous vancomycin with no morphine)

PLACEBO COMPARATOR

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

Experimental (Intraosseous vancomycin with morphine)

EXPERIMENTAL

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: Morphine; Drug: Vancomycin

Interventions

Morphine DRUG

10 mg morphine in 10 mL normal saline

Also known as: IO pain medication

Experimental (Intraosseous vancomycin with morphine)

Vancomycin DRUG

500 mg Vancomycin in 100 mL of normal saline

Also known as: IO antibiotic

Control (Intraosseous vancomycin with no morphine); Experimental (Intraosseous vancomycin with morphine)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Primary total knee arthroplasty
• Participants must be able to consent for themselves
• Capable and comfortable with text messaging

You may not qualify if:

• Non-primary total knee arthroplasty
• Intraoperative or postoperative deviation from standard of care
• Post-traumatic surgical indication
• Post-infectious surgical indication
• Chronic narcotic use or history of narcotic addiction
• Allergy to vancomycin
• Allergy to morphine
• Inability to receive spinal anesthesia
• Inability to receive intraoperative adductor canal block
• Inability to provide informed consent for the study
• Inability to speak English fluently

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Morphine; Vancomycin

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Joseph T Moskal, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, care team, and research team are all blinded to their respective group until the study is concluded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 43 patients receiving placebo. 43 patients receiving experimental.

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: December 4, 2024
• Study Start: December 1, 2024
• Primary Completion: May 15, 2025
• Study Completion: June 2, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

US (1)