Pain PostoperativeNCT06328062
Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA
A study testing Mirogabalin and Pregabalin in people with Pain Postoperative and Osteoarthritis, run by Thammasat University Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Pain Postoperative, Osteoarthritis, Total Knee Arthroplasty
- What is being tested?
- Mirogabalin and Pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-85 years old
- Unilateral primary osteoarthritis undergoing primary TKA
- ASA I-III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, 12120
Yot Tanariyakul, M.D., 6683930257, y.tanariyakul@gmail.com
Yot Tanariyakul, M.D.
About this study
Official title: 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 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.
- Conditions
- Pain Postoperative, Osteoarthritis, Total Knee Arthroplasty
- Being tested
- Mirogabalin, Pregabalin
- Keywords
- mirogabalin, pregabalin, pain postoperative, TKA
- Medical subject headings
- Pain, Postoperative, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirogabalinDrug
Participants will receive 5 mg of mirogabalin, twice a day, after breakfast and dinner, for 2 weeks.
PregabalinDrug
Participants will receive 75 mg of pregabalin, once a day before bedtime, for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mirogabalin | Experimental | Participants will receive 5 mg of mirogabalin, twice a day, after breakfast and dinner, for 2 weeks. Receives: Drug: Mirogabalin |
| Pregabalin | Active comparator | Participants will receive 75 mg of pregabalin, once a day before bedtime, for 2 weeks. Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Visual analog scale at rest and motion (0-100 points, 0 mean best, 100 mean worst)
Measured: 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 (7)
Morphine consumption
Total morphine consumption in hospital (mg)
Measured: 72 hours after surgery
Range of motion
Using long arm goniometer (degrees)
Measured: 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery
Knee society score
report in point (0-100, 0 mean worst, 100 mean best)
Measured: 2 week, 6 week and 12 week after surgery
Knee injury and Osteoarthritis Outcome Score (KOOS)
report in point (0-100, 0 mean worst, 100 mean best)
Measured: 2 week, 6 week and 12 week after surgery
Sedation score
report in point (0-100, 0 mean best, 100 mean worst)
Measured: 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery
Incidence of Somnolence and dizziness
Using scale "Mild, moderate and severe"
Measured: everyday until 14 days then once a week until 12 weeks after surgery
Total hospital stay
Number of days the patient stays for surgery
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Apr 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yot Tanariyakul, Thammasat University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328062
- Sponsor's protocol ID
- TUH Mirogabalin TKA
- Status last verified
- Aug 2026
- First submitted
- 8 Mar 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 32586656Kim 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Efficacy of Mirogabalin and Pregabalin in Total Knee Arthroplasty. a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06328062
- Acronym / sponsor ID
- TUH Mirogabalin TKA
- Conditions
- Pain Postoperative, Osteoarthritis, Total Knee Arthroplasty
- Keywords
- mirogabalin, pregabalin, pain postoperative, TKA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Thammasat University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirogabalin | Experimental | Drug: MirogabalinParticipants will receive 5 mg of mirogabalin, twice a day, after breakfast and dinner, for 2 weeks. |
| Pregabalin | Active comparator | Drug: PregabalinParticipants will receive 75 mg of pregabalin, once a day before bedtime, for 2 weeks. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50-85 years old
- Unilateral primary osteoarthritis undergoing primary TKA
- ASA I-III
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirogabalinParticipants will receive 5 mg of mirogabalin, twice a day, after breakfast and dinner, for 2 weeks. | Drug | Mirogabalin |
| PregabalinParticipants will receive 75 mg of pregabalin, once a day before bedtime, for 2 weeks. | Drug | Pregabalin |
Primary outcome
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)
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 32586656Hannon 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.
- Results publication: PubMed 33380563Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirogabalin and Pregabalin in people with Pain Postoperative and Osteoarthritis, run by Thammasat University Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yot Tanariyakul, M.D. (+66863930257, y.tanariyakul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06328062, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.