UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045480 |
|---|---|
| Receipt number | R000051922 |
| Scientific Title | The comparison of post operative pain control between intravenous patient-control-analgesia and acetaminophen -a randomized controlled study- |
| Date of disclosure of the study information | 2021/09/20 |
| Last modified on | 2023/04/13 11:31:57 |
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Basic information
Public title
The comparison of post operative pain control between intravenous patient-control-analgesia and acetaminophen -a randomized controlled study-
Acronym
The comparison of post operative pain control between intravenous patient-control-analgesia and acetaminophen -a randomized controlled study-
Scientific Title
The comparison of post operative pain control between intravenous patient-control-analgesia and acetaminophen -a randomized controlled study-
Scientific Title:Acronym
The comparison of post operative pain control between intravenous patient-control-analgesia and acetaminophen -a randomized controlled study-
Region
| Japan |
Condition
Condition
Osteoarthritis of the hip
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effect to reduce postoperative pain and nausea between intravenous patient-controlled-analgesia and oral and intravenous acetaminophen administration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
post operative pain following total hip arthroplasty at 1 day, 2 days, 4 days, and 7days after surgery.
Key secondary outcomes
post operative nausea at 1 day, 2 days, 4 days, and 7days 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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
comparison of iv-PCA and acetaminophen for postoperative pain control
Interventions/Control_2
comparison of iv-PCA and acetaminophen for postoperative pain control
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The persons undergone total hip arthroplasty
Key exclusion criteria
The persons with liver dysfunction, renal dysfunction, revision surgery, and to refuse the participate this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Imai |
Organization
Niigata University Graduate School
Division name
Div. of Comprehensive Musculoskeletal Medicine
Zip code
9518510
Address
1-757 Asahimachi-dori, Chuo Ward, Niigata City, Niigata Prefecture
TEL
0252272272
imainorio2001@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Imai |
Organization
Niigata
Division name
Div. of Comprehensive Musculoskeletal Medicine
Zip code
9518510
Address
1-757 Asahimachi-dori, Chuo Ward, Niigata City, Niigata Prefecture
TEL
0252272272
Homepage URL
imainorio2001@yahoo.co.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University
Address
1-757 Asahimachi-dori, Chuo Ward, Niigata City, Niigata Prefecture
Tel
0252272272
imainorio2001@yahoo.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2021-0013
Org. issuing International ID_1
Niigata University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
190
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
| 2021 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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 | 09 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051922
