Primary Total Knee ArthroplastyPhase 2NCT06716749
Effectiveness of Adding Morphine to Intraosseous Vancomycin for Pain Control in Total Knee Arthroplasty
A Phase 2 study testing Morphine and Vancomycin in people with Primary Total Knee Arthroplasty and Intraosseous Morphine Injection, run by Carilion Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Primary Total Knee Arthroplasty, Intraosseous Morphine Injection, Knee Osteoarthritis
- What is being tested?
- Morphine and Vancomycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 2 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-100 years old
- Primary total knee arthroplasty
- Participants must be able to consent for themselves
- Capable and comfortable with text messaging
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Morphine, Vancomycin
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Also called IO pain medication
10 mg morphine in 10 mL normal saline
VancomycinDrug
Also called IO antibiotic
500 mg Vancomycin in 100 mL of normal saline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Morphine; Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain levels
Pain scores on a scale of 0-10 with 0 meaning no pain and 10 being the worst pain possible
Measured: 14 days postoperatively
Postoperative pain medication consumption
How much pain medication patients consumed following surgery. Measured in morphine milliequivalents (MME).
Measured: 14 days postoperatively
Secondary outcomes (3)
Number of patients with postoperative nausea and vomiting
Number of patients with postoperative nausea and vomiting episodes within 14 days of surgery
Measured: 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.
Measured: 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.
Measured: 1 month preoperative to 6 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Dec 2024
- Primary completion15 May 2025
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 43 patients receiving placebo. 43 patients receiving experimental.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph T Moskal, MD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716749
- Sponsor's protocol ID
- IRB-24-1831
- Status last verified
- Sep 2025
- First submitted
- 17 Nov 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Adding Morphine to Intraosseous Vancomycin for Pain Control in Total Knee Arthroplasty: A Double-Blind, Randomized Trial
- ClinicalTrials.gov ID
- NCT06716749
- Acronym / sponsor ID
- IRB-24-1831
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 43 patients receiving placebo. 43 patients receiving experimental.
| Arm | Type | Receives |
|---|---|---|
| Control (Intraosseous vancomycin with no morphine) | Placebo comparator | Drug: VancomycinControl 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) | Experimental | Drug: Morphine, Drug: VancomycinControl 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-100 years old
- Primary total knee arthroplasty
- Participants must be able to consent for themselves
- Capable and comfortable with text messaging
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineAlso: IO pain medication10 mg morphine in 10 mL normal saline | Drug | Experimental (Intraosseous vancomycin with morphine) |
| VancomycinAlso: IO antibiotic500 mg Vancomycin in 100 mL of normal saline | Drug | Control (Intraosseous vancomycin with no morphine), Experimental (Intraosseous vancomycin with morphine) |
Primary outcome
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
Postoperative pain medication consumption
Time frame: 14 days postoperatively
How much pain medication patients consumed following surgery. Measured in morphine milliequivalents (MME).
3 secondary outcomes
Number of patients with postoperative nausea and vomiting
Time frame: 14 days postoperatively
Patient reported outcomes (KOOS)
Time frame: 1 month preoperative to 6 weeks postoperative
Patient reported outcomes (PROMIS)
Time frame: 1 month preoperative to 6 weeks postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph T Moskal, MD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Morphine and Vancomycin in people with Primary Total Knee Arthroplasty and Intraosseous Morphine Injection, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain levels (time frame: 14 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.