Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA
NCT ID: NCT06328062
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-04-01
2025-05-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Mirogabalin
Participants will receive 5 mg of mirogabalin, taken as half a tablet, every day twice a day, after breakfast and dinner, for 6 weeks.
Mirogabalin
Participants will receive 5 mg of mirogabalin, taken as half a tablet, every day twice a day, after breakfast and dinner, for 6 weeks.
Pregabalin
Participants will receive 50 mg of pregabalin, taken as a tablet, every day twice a day, after breakfast and dinner, for 6 weeks.
Pregabalin
Participants will receive 50 mg of pregabalin, taken as a tablet, every day twice a day, after breakfast and dinner, for 6 weeks.
Interventions
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Mirogabalin
Participants will receive 5 mg of mirogabalin, taken as half a tablet, every day twice a day, after breakfast and dinner, for 6 weeks.
Pregabalin
Participants will receive 50 mg of pregabalin, taken as a tablet, every day twice a day, after breakfast and dinner, for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Unilateral primary osteoarthritis undergoing primary TKA
3. ASA I-III
Exclusion Criteria
2. Allergy to drug in this study
3. Cannot underwent spinal anesthesia and adductor canal block
4. Taking gabapentinoid within 3 months before surgery
5. History of previous knee surgery
6. Severe liver disease
50 Years
85 Years
ALL
No
Sponsors
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Thammasat University Hospital
OTHER
Responsible Party
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Yot Tanariyakul
Principle investigator
Locations
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Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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Hannon CP, Fillingham YA, Browne JA, Schemitsch EH, Mullen K, Casambre F, Visvabharathy V, Hamilton WG, Della Valle CJ. The Efficacy and Safety of Gabapentinoids in Total Joint Arthroplasty: Systematic Review and Direct Meta-Analysis. J Arthroplasty. 2020 Oct;35(10):2730-2738.e6. doi: 10.1016/j.arth.2020.05.033. Epub 2020 May 26.
Kim JY, Abdi S, Huh B, Kim KH. Mirogabalin: could it be the next generation gabapentin or pregabalin? Korean J Pain. 2021 Jan 1;34(1):4-18. doi: 10.3344/kjp.2021.34.1.4.
Other Identifiers
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TUH Mirogabalin TKA
Identifier Type: -
Identifier Source: org_study_id
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