Mirogabalin for Total Hip Arthroplasty

Mirogabalin and Pain After Total Hip Arthroplasty: a Double-blind, Randomized, Placebo-controlled Trial

The purpose of this study is to confirm the analgesic effect of mirogabalin in patients undergoing unilateral hip arthroplasty.

Study Overview

• Status: Recruiting
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Drug: Arm I (mirogabalin group); Drug: Arm II (placebo group)

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Do-Hyeong Kim; Phone Number: 02-2019-3555; Email: BREADFANS@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Gangnam Severance Hospital
    • Contact: Ji Yeong Kim; Phone Number: 82-2-2019-4601

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
2. American Society of Anesthesiologists class 1-3

Exclusion Criteria:

1. Major prior ipsilateral open hip surgery
2. Allergies to drugs used in research
3. Difficult to manage diabetes mellitus (including insulin dependence)
4. Chronic use of gabapentin or pregabalin (regular use for more than 3 months)
5. Patients taking cimetidine, probenecid, or lorazepam
6. Patients with moderate or severe hepatic impairment (AST/ALT 2.5 times or more of the upper limit of normal)
7. Estimated glomerular filtration rate < 60 mL/min/1.73m2
8. Dependence on opioids
9. In the case of subjects who cannot read the consent form (e.g. illiterate, foreigners, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mirogabalin group; perioperative mirogabalin	Drug: Arm I (mirogabalin group); Take two capsules of Mirogabalin 5 mg within 30 minutes before going to the operating room. Patients take 5 mg of mirogabalin twice daily at 12-hour intervals until POD 7 days.
Sham Comparator: placebo group; placebo	Drug: Arm II (placebo group); It is performed in the same way as Arm l.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numeric rating scale at flexion	A score of 0 indicates no pain and a score of 10 indicates maximum pain.	postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numeric rating scale at flexion	A score of 0 indicates no pain and a score of 10 indicates maximum pain.	up to 3 month after surgery

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Estimated): June 28, 2025
• Study Completion (Estimated): June 28, 2025

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 3-2023-0151

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No