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Study was not conducted because funding was not obtained.
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The purpose of this study is to determine if Duloxetine provides effective pain management for adult patients (18 or older) undergoing tibial plateau surgery. Participants from two institutions will be randomized to one of two treatment groups: control (Group A) and treatment (Group B). Group A control group will receive placebo of sugar pill and BMC standard of care - namely postoperative, IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump (BMC standard of care). Group B, the intervention group, will receive three doses of 60 mg of oral duloxetine (right before operation, postop day 1, postop day 2).
This study is important as tibial plateau surgery's postoperative pain management primarily involved providing opioids, and if duloxetine can result in reduced narcotic intake and lower pain scores, it can potentially improve patient care, rehabilitation, early movement, and shorter length of hospital stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A Placebo | Active Comparator | Participants randomized to Group A will receive placebo (sugar pill) and Boston Medical Center (BMC) standard of care. |
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| Groups B Intervention | Experimental | Participants randomized to Group B will receive duloxetine and Boston Medical Center (BMC) standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Three doses of 60 mg of oral duloxetine will be given to participants (right before operation, postop day 1, postop day 2) |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain levels in the first 16 hours after surgery | A visual analog pain scale (VAS) will be used to assess postoperative pain levels. Participants will make a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." HIgher scores reflect greater pain levels. | every 4 hours up to 16 hours |
| Pain level 24 hours after surgery | A visual analog pain scale (VAS) will be used to assess the postoperative pain level. Participants will make a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." HIgher scores reflect greater pain levels. | 24 hours |
| Pain level 36 hours after surgery | A visual analog pain scale (VAS) will be used to assess the postoperative pain level. Participants will make a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." HIgher scores reflect greater pain levels. | 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine consumption | The total morphine consumption will be calculated using the Centers for Disease Control (CDC) morphine equivalents [ME].Determine the total daily amount of morphine taken; convert to MEs by multiplying the daily dosage for each opioid by its conversion factor [which is =1 for morphine]; then add all morphine MEs together. | up to 10 days post op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seroos Salavati, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States | ||
| Westchester Medical Center |
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| ID | Term |
|---|---|
| D000092463 | Tibial Plateau Fractures |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D000092443 | Knee Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D013978 | Tibial Fractures |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| D000073893 | Sugars |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Placebo | Other | Three doses of placebo will be given to participants (right before operation, postop day 1, postop day 2). |
|
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| Standard of care (SOC) for tibial plateau surgery | Other | Postoperative IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump. |
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| Change in knee range of motion | The knee range of motion will be abstracted from the electronic medical record. Knee range of motion ranges from 0 to 140 degrees. | 6 weeks, 12 weeks |
| Self reported functional status at 6 weeks | Functional status will be assessed using the Short Musculoskeletal Function Assessment (SMFA). SMFA is a 46 item questionnaire. It consists of the dysfunction index, which has 34 items for the assessment of patient function, and the bother index, which has 12 items for the assessment of how much patients are bothered by functional problems. | 6 weeks |
| Self reported functional status at 12 weeks | Functional status will be assessed using the Short Musculoskeletal Function Assessment (SMFA). SMFA is a 46 item questionnaire. It consists of the dysfunction index, which has 34 items for the assessment of patient function, and the bother index, which has 12 items for the assessment of how much patients are bothered by functional problems. | 12 weeks |
| Hospital length of stay | The hospital length of stay will be measured in days, calculated by subtracting the date of admission from the date of discharge as recorded in the electronic medical record. | 12 weeks |
| Time to mobilization (starting to walk) | The time to mobilization will be calculated by subtracting the date the participant started to walk post operatively from the date of surgery as recorded in the electronic medical record. | 12 weeks |
| Ambulation (walking) distance on post-op days 1 or 2 | The walking distance will be abstracted from the electronic medical record. | Up to 2 days post op |
| Valhalla |
| New York |
| 10595 |
| United States |
| D007718 |
| Knee Injuries |
| D007869 | Leg Injuries |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D002241 | Carbohydrates |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |