Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA

March 20, 2024 updated by: Yot Tanariyakul, Thammasat University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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, 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

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Pathum Thani
      • Khlong Luang, Pathum Thani, Thailand, 12120
        • Recruiting
        • Thammasat University Hospital
        • Principal Investigator:
          • Krit Boontanapibul, M.D.
        • Contact:
        • Principal Investigator:
          • Yot Tanariyakul, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Active Comparator: Pregabalin
Participants will receive 50 mg of pregabalin, taken as a tablet, every day twice a day, after breakfast and dinner, for 6 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Visual analog scale at rest and motion (0-100 points, 0 mean best, 100 mean worst)
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

Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: 72 hours after surgery
Total morphine consumption in hospital (mg)
72 hours after surgery
Range of motion
Time Frame: 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery
Using long arm goniometer (degrees)
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
report in point (0-100, 0 mean worst, 100 mean best)
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
report in point (0-100, 0 mean worst, 100 mean best)
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
report in point (0-100, 0 mean best, 100 mean worst)
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
Using scale "Mild, moderate and severe"
everyday until 14 days then once a week until 12 weeks after surgery
Total hospital stay
Time Frame: up to 1 week
Number of days the patient stays for surgery
up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUH Mirogabalin TKA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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