NCT Number: NCT06328062
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.
Interested in participating?
Request Info50 year–85 year
All sexes
Interventional
Not applicable
Khlong Luang, Changwat Pathum Thani, 12120, Thailand
Location status: Recruiting
Krit Boontanapibul, M.D.
PRINCIPAL_INVESTIGATOR
Yot Tanariyakul, M.D.
CONTACT
Yot Tanariyakul, M.D.
PRINCIPAL_INVESTIGATOR
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Visual analog scale at rest and motion (0-100 points, 0 mean best, 100 mean worst)
Time frame: 72 hours after surgery
Total morphine consumption in hospital (mg)
Time frame: 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery
Using long arm goniometer (degrees)
Time frame: 2 week, 6 week and 12 week after surgery
report in point (0-100, 0 mean worst, 100 mean best)
Time frame: 2 week, 6 week and 12 week after surgery
report in point (0-100, 0 mean worst, 100 mean best)
Time frame: 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery
report in point (0-100, 0 mean best, 100 mean worst)
Time frame: everyday until 14 days then once a week until 12 weeks after surgery
Using scale "Mild, moderate and severe"
Time frame: up to 1 week
Number of days the patient stays for surgery
Contact information is provided by the study sponsor or research team.
Thammasat University Hospital
Other
Comparison Efficacy of Mirogabalin and Pregabalin in Total Knee Arthroplasty. a Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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