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Morphine + Vancomycin for Pain Control After Knee Replacement

Phase 2

Waitlist Available

Led By Joseph T Moskal, MD

Research Sponsored by Carilion Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-100 years old

Primary total knee arthroplasty

Must not have

Non-primary total knee arthroplasty

Inability to receive spinal anesthesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month preoperative to 6 weeks postoperative

Summary

This trial will look at whether giving pain medication directly into the bone during knee replacement surgery helps with pain levels afterward. They will enroll 86 patients who will either receive antibiotics with morphine (pain medication

Who is the study for?

This trial is for patients undergoing primary knee replacement surgery due to osteoarthritis. Participants must be suitable for receiving intraosseous injections (directly into the bone) of medication during the procedure.

What is being tested?

The study tests if adding morphine to a standard bony injection of vancomycin, an antibiotic, can better manage pain after knee replacement surgery. Patients are randomly divided into two groups: one receives vancomycin with morphine and the other gets vancomycin with a placebo.

What are the potential side effects?

Potential side effects may include typical reactions to morphine such as nausea, drowsiness, constipation, or itching. There might also be local discomfort at the injection site in the tibia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 100 years old.

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I have had a total knee replacement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am getting or have had a knee replacement that isn't my first.

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I cannot have spinal anesthesia.

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I cannot have a specific type of anesthesia for surgery.

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My surgery didn't follow the usual procedure.

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I need surgery due to an injury.

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I need surgery due to a complication from an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month preoperative to 6 weeks postoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month preoperative to 6 weeks postoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month preoperative to 6 weeks postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postoperative pain levels

Postoperative pain medication consumption

Secondary study objectives

Number of patients with postoperative nausea and vomiting

Patient reported outcomes (KOOS)

Patient reported outcomes (PROMIS)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental (Intraosseous vancomycin with morphine)Experimental Treatment2 Interventions

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.

Group II: Control (Intraosseous vancomycin with no morphine)Placebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Morphine

2013

Completed Phase 4

~2230

Vancomycin

2020

Completed Phase 4

~7920