CClinicalTrials.gg
RecruitingNCT06328062Updated Aug 7, 2026

Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA

An interventional study of Mirogabalin and Pregabalin in Pain Postoperative, Osteoarthritis and Total Knee Arthroplasty, sponsored by Thammasat University Hospital. Recruiting at 1 site in Thailand. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Thammasat University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pain Postoperative
  • Osteoarthritis
  • Total Knee Arthroplasty

Keywords

  • mirogabalin
  • pregabalin
  • pain postoperative
  • TKA
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 80 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Thammasat University Hospital is the lead sponsor of 16 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Mirogabalin

    Participants will receive 5 mg of mirogabalin, twice a day, after breakfast and dinner, for 2 weeks.

    Drug: Mirogabalin

  • Active comparator
    Pregabalin

    Participants will receive 75 mg of pregabalin, once a day before bedtime, for 2 weeks.

    Drug: Pregabalin

Interventions

  • DrugMirogabalin

    Participants will receive 5 mg of mirogabalin, twice a day, after breakfast and dinner, for 2 weeks.

  • DrugPregabalin

    Participants will receive 75 mg of pregabalin, once a day before bedtime, for 2 weeks.

06

What researchers measure

Primary outcomes

  1. Pain score

    Visual analog scale at rest and motion (0-100 points, 0 mean best, 100 mean worst)

    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 outcomes

  1. Morphine consumption

    Total morphine consumption in hospital (mg)

    Time frame: 72 hours after surgery

  2. Range of motion

    Using long arm goniometer (degrees)

    Time frame: 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery

  3. Knee society score

    report in point (0-100, 0 mean worst, 100 mean best)

    Time frame: 2 week, 6 week and 12 week after surgery

  4. Knee injury and Osteoarthritis Outcome Score (KOOS)

    report in point (0-100, 0 mean worst, 100 mean best)

    Time frame: 2 week, 6 week and 12 week after surgery

  5. Sedation score

    report in point (0-100, 0 mean best, 100 mean worst)

    Time frame: 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery

  6. Incidence of Somnolence and dizziness

    Using scale "Mild, moderate and severe"

    Time frame: everyday until 14 days then once a week until 12 weeks after surgery

  7. Total hospital stay

    Number of days the patient stays for surgery

    Time frame: up to 1 week

07

Study locations

1 of 1 sites recruiting
  • Thammasat University Hospital
    Khlong Luang, Changwat Pathum Thani 12120, Thailand
    • Yot Tanariyakul, M.D. · Contact · y.tanariyakul@gmail.com · 6683930257
    • Yot Tanariyakul, M.D. · Principal investigator
    • Krit Boontanapibul, M.D. · Principal investigator
    Recruiting
08

References and documents

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. PubMed 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. PubMed 33380563 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06328062
Lead sponsor
Thammasat University Hospital
Responsible party
Yot Tanariyakul (Principle investigator, Thammasat University Hospital) — Principal investigator
First posted
Mar 25, 2024
Start date
Apr 1, 2024
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Aug 7, 2026

Study contacts

Yot Tanariyakul, M.D.
Contact
y.tanariyakul@gmail.com
+66863930257

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion