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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Three doses of 60 mg of oral duloxetine will be given to participants (right before operation, postop day 1, postop day 2)
Three doses of placebo will be given to participants (right before operation, postop day 1, postop day 2).
Postoperative IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump.
Boston Medical Center
Boston, Massachusetts, United States
Westchester Medical Center
Valhalla, New York, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 36 hours
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.
Time frame: up to 10 days post op
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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Ambulation (walking) distance on post-op days 1 or 2
The walking distance will be abstracted from the electronic medical record.
Time frame: Up to 2 days post op