UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of Mirogabalin and pain after total hip arthroplasty: a randomized controlled trial
Acronym	Efficacy of Mirogabalin and pain after total hip arthroplasty: a randomized controlled trial
Scientific Title	Efficacy of Mirogabalin and pain after total hip arthroplasty: a randomized controlled trial
Scientific Title:Acronym	Efficacy of Mirogabalin and pain after total hip arthroplasty: a randomized controlled trial
Region	Japan

Condition
Condition	Hip osteoarthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The authors of the present study conducted a randomized controlled trial to investigate the efficacy of milogabalin on the postoperative morphine consumption and side-effects, and pain score in patients undergoing THA.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome was total fentanyl consumption over the initial 24h postoperatively.
Key secondary outcomes	The postoperative numerical rating scale (NRS) at rest, the active, and passive NRS score during hip exercise. Chronic pain was evaluated using a chronic pain grading scale (CPGS) at 6 months after surgery.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Mirogabalin 15mg was given at 2 hours before surgery. From 24 hours after surgery, study group patients received mirogabalin (15mg twice per day) for 2 days.
Interventions/Control_2	On the day of surgery, postoperative pain treatment consisted of two times intravenous acetaminophen 1000mg every 6 hours and an intravenous patient-controlled analgesia (PCA) fentanyl pump for 24 hours (The total volume of PCA was calculated from patient body weight) initiated immediately after back to the ward. The PCA pump was set to deliver fentanyl 50microgram/dose on demand with a 30 min lockout interval and no background infusion. However, the administration of intravenous acetaminophen was reduced to15mg/kg for patients with less than 50kg of body weight. From 24 hours after surgery, all patients were given oral acetaminophen (500mg every 8h) and celecoxib (100mg twice per day) for 7 days.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients recruited were of the American Society of Anesthesiologists (ASA) grade 1-3 rating, unilateral primary THA under general anesthesia, and the ability to cooperate with the investigation and understand the pain scale.
Key exclusion criteria	Exclusion criteria included patients with dementia or mental disorders, known drug allergy or tolerance to study drugs, renal insufficiency or abnormal liver enzymes, severe cardiovascular disease, severe diabetes, who have not been used the modified Watson-Jones approach, who have undergone bilateral simultaneous THA, and who have not passed more than 6 months from previous the other side THA.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Shigeo Middle name Last name Fukunishi
Organization	Nishinomiya Kaisei hospital
Division name	Department of Orthopaedics
Zip code	662-0957
Address	4-1, Ohama-cho, Nishinomiya, Hyogo, Japan
TEL	0798-33-0601
Email	fukunishi.shigeo@hmw.gr.jp

Public contact
Name of contact person	1st name Yu Middle name Last name Takeda
Organization	Nishinomiya Kaisei hospital
Division name	Department of Orthopaedics
Zip code	662-0957
Address	4-1, Ohama-cho, Nishinomiya, Hyogo, Japan
TEL	0798-33-0601
Homepage URL
Email	takeda.yu.0127@gmail.com

Sponsor
Institute	Nishinomiya Kaisei hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nishinomiya Kaisei hospital
Address	4-1, Ohama-cho, Nishinomiya, Hyogo, Japan
Tel	0798-33-0601
Email	None

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人社団　西宮回生病院

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2020 Year 07 Month 20 Day
Date of IRB	2020 Year 06 Month 20 Day
Anticipated trial start date	2020 Year 07 Month 20 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 04 Day
Last modified on	2021 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048969

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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