NCT06328062

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

1.2 years

First QC Date

March 8, 2024

Last Update Submit

April 5, 2025

Conditions

Pain PostoperativeOsteoarthritisTotal Knee Arthroplasty

Keywords

mirogabalinpregabalinpain postoperativeTKA

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Morphine consumption

    72 hours after surgery

  • Range of motion

    24 hour, 48 hour, 2 week, 6 week and 12 week after surgery

  • Knee society score

    2 week, 6 week and 12 week after surgery

  • Knee injury and Osteoarthritis Outcome Score (KOOS)

    2 week, 6 week and 12 week after surgery

  • Sedation score

    24 hour, 48 hour, 2 week, 6 week and 12 week after surgery

  • +2 more secondary outcomes

Study Arms (2)

Mirogabalin

EXPERIMENTAL

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

Drug: Mirogabalin

Pregabalin

ACTIVE COMPARATOR

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

Drug: Pregabalin

Interventions

MirogabalinDRUG

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

Mirogabalin
PregabalinDRUG

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

Pregabalin

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50-85 years old
  • Unilateral primary osteoarthritis undergoing primary TKA
  • ASA I-III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thammasat University Hospital

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

RECRUITING

Related 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 Oct;35(10):2730-2738.e6. doi: 10.1016/j.arth.2020.05.033. Epub 2020 May 26.

    PMID: 32586656BACKGROUND

  • 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.

    PMID: 33380563BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeOsteoarthritis

Interventions

mirogabalinPregabalin

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Central Study Contacts

Yot Tanariyakul, M.D.

CONTACT

+66863930257y.tanariyakul@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 8, 2024

First Posted

March 25, 2024

Study Start

April 1, 2024

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)