Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA

Thammasat University Hospital

Status: Enrolling

Conditions: Osteoarthritis; Pain Postoperative; Total Knee Arthroplasty

Treatments: Drug: Mirogabalin; Drug: Pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT06328062

TUH Mirogabalin TKA

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Mirogabalin

Experimental group

Description:

Participants will receive 5 mg of mirogabalin, taken as half a tablet, every day twice a day, after breakfast and dinner, for 6 weeks.

Treatment:

Drug: Mirogabalin

Pregabalin

Active Comparator group

Description:

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

Treatment:

Drug: Pregabalin