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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-06-02

Brief Summary

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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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Detailed Description

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Conditions

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Primary Total Knee Arthroplasty Intraosseous Morphine Injection Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

43 patients receiving placebo. 43 patients receiving experimental.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Patients, care team, and research team are all blinded to their respective group until the study is concluded.

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Vancomycin

Intervention Type DRUG

500 mg Vancomycin in 100 mL of normal saline

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.

Group Type EXPERIMENTAL

Morphine

Intervention Type DRUG

10 mg morphine in 10 mL normal saline

Vancomycin

Intervention Type DRUG

500 mg Vancomycin in 100 mL of normal saline

Interventions

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Morphine

10 mg morphine in 10 mL normal saline

Intervention Type DRUG

Vancomycin

500 mg Vancomycin in 100 mL of normal saline

Intervention Type DRUG

Other Intervention Names

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IO pain medication IO antibiotic

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No