Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA

NCT ID: NCT06328062

Last Updated: 2025-04-09

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-05-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Pain Postoperative Osteoarthritis Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Group Type EXPERIMENTAL

Mirogabalin

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

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.

Intervention Type DRUG

Pregabalin

Participants will receive 50 mg of pregabalin, taken as a tablet, every day twice a day, after breakfast and dinner, for 6 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age 50-85 years old
2. Unilateral primary osteoarthritis undergoing primary TKA
3. ASA I-III

Exclusion Criteria

1. GFR \<60
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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thammasat University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yot Tanariyakul

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Thammasat University Hospital

Khlong Luang, Changwat Pathum Thani, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Yot Tanariyakul, M.D.

Role: CONTACT

+66863930257

Facility Contacts

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Yot Tanariyakul, M.D.

Role: primary

6683930257

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.

Reference Type BACKGROUND
PMID: 32586656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33380563 (View on PubMed)

Other Identifiers

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TUH Mirogabalin TKA

Identifier Type: -

Identifier Source: org_study_id

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