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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06328062
Other study ID # TUH Mirogabalin TKA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date May 31, 2025

Study information

Verified date March 2024
Source Thammasat University Hospital
Contact Yot Tanariyakul, M.D.
Phone +66863930257
Email y.tanariyakul@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Thailand Thammasat University Hospital Khlong Luang Pathum Thani

Sponsors (1)

Lead Sponsor Collaborator
Thammasat University Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

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 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain score 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 Morphine consumption Total morphine consumption in hospital (mg) 72 hours after surgery
Secondary Range of motion Using long arm goniometer (degrees) 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery
Secondary Knee society score report in point (0-100, 0 mean worst, 100 mean best) 2 week, 6 week and 12 week after surgery
Secondary Knee injury and Osteoarthritis Outcome Score (KOOS) report in point (0-100, 0 mean worst, 100 mean best) 2 week, 6 week and 12 week after surgery
Secondary Sedation score report in point (0-100, 0 mean best, 100 mean worst) 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery
Secondary Incidence of Somnolence and dizziness Using scale "Mild, moderate and severe" everyday until 14 days then once a week until 12 weeks after surgery
Secondary Total hospital stay Number of days the patient stays for surgery up to 1 week
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