UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000042898 |
|---|---|
| Receipt number | R000048969 |
| Scientific Title | Efficacy of Mirogabalin and pain after total hip arthroplasty: a randomized controlled trial |
| Date of disclosure of the study information | 2021/01/05 |
| Last modified on | 2023/11/21 15:33:15 |
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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
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
takeda.yu.0127@gmail.com
Sponsor or person
Institute
Nishinomiya Kaisei hospital
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 07 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 20 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 04 | Day |
Last modified on
| 2023 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048969
