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Recruiting NCT06328062

Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA

No phase Interventional Pain Postoperative Osteoarthritis Total Knee Arthroplasty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mirogabalin, Pregabalin.
Who it may be relevant to
Registry conditions: Pain Postoperative, Osteoarthritis, Total Knee Arthroplasty. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison Efficacy of Mirogabalin and Pregabalin in Total Knee Arthroplasty. a Randomized Controlled Trial

Overview

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 2 weeks after TKA. Researchers will compare to pregabalin group to see pain and functional outcomes after TKA.

Detailed description

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, one tablet taken twice a day, after breakfast and dinner, for 2 weeks.

In the pregabalin group: Participants received 75 mg of pregabalin, one tablet taken daily before bedtime, for 2 weeks.

Interventions

  • Drug Mirogabalin
    Participants will receive 5 mg of mirogabalin, twice a day, after breakfast and dinner, for 2 weeks.
  • Drug Pregabalin
    Participants will receive 75 mg of pregabalin, once a day before bedtime, for 2 weeks.

Primary outcome measures

  • Pain score [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.]
Secondary outcome measures (7)
  • Morphine consumption [Time frame: 72 hours after surgery]
  • Range of motion [Time frame: 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery]
  • Knee society score [Time frame: 2 week, 6 week and 12 week after surgery]
  • Knee injury and Osteoarthritis Outcome Score (KOOS) [Time frame: 2 week, 6 week and 12 week after surgery]
  • Sedation score [Time frame: 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery]
  • Incidence of Somnolence and dizziness [Time frame: everyday until 14 days then once a week until 12 weeks after surgery]
  • Total hospital stay [Time frame: up to 1 week]

Eligibility criteria

Inclusion criteria

  • Age 50-85 years old
  • Unilateral primary osteoarthritis undergoing primary TKA
  • ASA I-III

Exclusion criteria

  • GFR \<60
  • Allergy to drug in this study
  • Cannot underwent spinal anesthesia and adductor canal block
  • Taking gabapentinoid within 3 months before surgery
  • History of previous knee surgery
  • Severe liver disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • Thammasat University Hospital — Khlong Luang

Publications

  • 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. PMID 32586656
  • 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. PMID 33380563

Identifiers

NCT: NCT06328062 · TUH Mirogabalin TKA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗