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OpenTrials
Completed

NCT Number: NCT06716749

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

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.

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Key information

Conditions

Primary Total Knee Arthroplasty Arthritis Intraosseous Morphine Injection Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Carilion Clinic

Roanoke, Virginia, 24014, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-100 years old
  • Primary total knee arthroplasty
  • Participants must be able to consent for themselves
  • Capable and comfortable with text messaging

Exclusion criteria

  • 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

Treatment and study plan

Morphine

Drug

10 mg morphine in 10 mL normal saline

Other names: IO pain medication

Vancomycin

Drug

500 mg Vancomycin in 100 mL of normal saline

Other names: IO antibiotic

Primary outcomes

  1. Postoperative pain levels

    Time frame: 14 days postoperatively

    Pain scores on a scale of 0-10 with 0 meaning no pain and 10 being the worst pain possible

  2. Postoperative pain medication consumption

    Time frame: 14 days postoperatively

    How much pain medication patients consumed following surgery. Measured in morphine milliequivalents (MME).

Secondary outcomes

  1. Number of patients with postoperative nausea and vomiting

    Time frame: 14 days postoperatively

    Number of patients with postoperative nausea and vomiting episodes within 14 days of surgery

  2. Patient reported outcomes (KOOS)

    Time frame: 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.

  3. Patient reported outcomes (PROMIS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Carilion Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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