Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06328062
• Other study ID #: TUH Mirogabalin TKA
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Pain Postoperative
• Pain, Postoperative
• Total Knee Arthroplasty

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