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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine | Drug | 10 mg morphine in 10 mL normal saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with postoperative nausea and vomiting | Number of patients with postoperative nausea and vomiting episodes within 14 days of surgery | 14 days postoperatively |
| Patient reported outcomes (KOOS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph T Moskal, MD | Carilion Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carilion Clinic | Roanoke | Virginia | 24014 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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43 patients receiving placebo. 43 patients receiving experimental.
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Patients, care team, and research team are all blinded to their respective group until the study is concluded.
| Vancomycin | Drug | 500 mg Vancomycin in 100 mL of normal saline |
|
|
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.
| 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. | 1 month preoperative to 6 weeks postoperative |
| D012216 |
| Rheumatic Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |