Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA

Not Applicable

Recruiting

• Conditions: Osteoarthritis; Pain Postoperative; Total Knee Arthroplasty
• Interventions: Drug: Mirogabalin; Drug: Pregabalin

• Registration Number: NCT06328062
• Lead Sponsor: Thammasat University Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-25
• Study Start: 2024-04-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-05
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pain score	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Thammasat University Hospital; 🇹🇭 Khlong Luang, Pathum Thani, Thailand