The goal of this RCT is to compare efficacy between mirogabalin and pregabalin in pain reducing after unilateral primary total knee arthroplasty. The main question\[s\] it aims to answer are: • Does mirogabalin have better pain reduction than pregabalin after unilateral primary total knee arthroplasty. Participants will randomized to mirogabalin or pregabalin group and will take the drug for 6 weeks after TKA. Researchers will compare to pregabalin group to see pain and functional outcomes after TKA.
After surgery is complete, you will be randomly assigned to receive painkillers Mirogabalin or Pregabalin along with other standard medications. Surgery by Mirogabalin group: Participants received 5 mg of mirogabalin, taken as half a tablet, every day. Twice a day, after breakfast and dinner, for 6 weeks. In the pregabalin group: Participants received 50 mg of pregabalin, one tablet taken daily. Twice a day, after breakfast and dinner, for 6 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Participants will receive 5 mg of mirogabalin, taken as half a tablet, every day twice a day, after breakfast and dinner, for 6 weeks.
Participants will receive 50 mg of pregabalin, taken as a tablet, every day twice a day, after breakfast and dinner, for 6 weeks.
Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, Thailand
RECRUITINGPain score
Visual analog scale at rest and motion (0-100 points, 0 mean best, 100 mean worst)
Time frame: Every 6 hours after surgery for 2 days, then twice a day for 2 weeks, then once a week until 12 week after surgery.
Morphine consumption
Total morphine consumption in hospital (mg)
Time frame: 72 hours after surgery
Range of motion
Using long arm goniometer (degrees)
Time frame: 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery
Knee society score
report in point (0-100, 0 mean worst, 100 mean best)
Time frame: 2 week, 6 week and 12 week after surgery
Knee injury and Osteoarthritis Outcome Score (KOOS)
report in point (0-100, 0 mean worst, 100 mean best)
Time frame: 2 week, 6 week and 12 week after surgery
Sedation score
report in point (0-100, 0 mean best, 100 mean worst)
Time frame: 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery
Incidence of Somnolence and dizziness
Using scale "Mild, moderate and severe"
Time frame: everyday until 14 days then once a week until 12 weeks after surgery
Total hospital stay
Number of days the patient stays for surgery
Time frame: up to 1 week
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