UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022778 |
|---|---|
| Receipt number | R000026185 |
| Scientific Title | Study of effectiveness of acetaminophen for the postoperative pain after total hip arthroplasty |
| Date of disclosure of the study information | 2016/06/17 |
| Last modified on | 2019/03/10 20:04:46 |
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Basic information
Public title
Study of effectiveness of acetaminophen for the postoperative pain after total hip arthroplasty
Acronym
Study of effectiveness of acetaminophen for the postoperative pain after total hip arthroplasty
Scientific Title
Study of effectiveness of acetaminophen for the postoperative pain after total hip arthroplasty
Scientific Title:Acronym
Study of effectiveness of acetaminophen for the postoperative pain after total hip arthroplasty
Region
| Japan |
Condition
Condition
hip osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Previous study reported, nerve blocks were effective in the perioperative pain after total hip arthroplasty. We performed one-hundred cases at our hospital a year. We used fentanyl intravenous injection and femoral nerve block for post-operative pain. These treatments were effective but patients developed mild or moderate pain yet. When the patients were caused sever post-operative pain, we usually used Non-Steroidal Anti-Inflammatory Drugs. These drugs were difficult for renal dysfunction patients or gastric ulcer patients to use. In this study, we used acetaminophen intravenous injection for postoperative pain within 24 hours and we evaluated condition of the improvement of this pain. If we proved usefulness of acetaminophen intravenous injection, we will be able to use for postoperative pain control as one of choice in comparison with NSAIDs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Pre-operative assessment
Numerical Rating Scale (NRS) value.
Post-operative assessment
NRS (0 hour, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours)
Key secondary outcomes
Patient Controlled Analgesia used amount
Opioid consumption volume of 24 hours
Postoperative liver function evaluation during 2weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
From date of approval march 2016 to 31 march 2018.
All patients were performed total hip arthroplasty.
A : 50 patients used acetaminophen intravenous
All patients were randomly selected.
Acetaminophen was gave medication 4 times to patients within 24 hours.
All patients were used femoral nerve block and intravenous fentanyl.
Interventions/Control_2
From date of approval march 2016 to 31 march 2018.
All patients were performed total hip arthroplasty.
B : 50 patients unused acetaminophen intravenous
All patients were randomly selected.
All patients were used femoral nerve block and intravenous fentanyl.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient who received the primary total hip arthroplasty which was not included in exclusion criteria.
Key exclusion criteria
Patients have a liver function disorder, a renal function disorder.
In disease severity of the liver function, we exclude the cases more than grade 2 or class B from the object of this study with "pharmaceutical products side effect serious degree classification" "Child-Pugh classification".
In disease severity of the renal function, we excluded the case of Ccr<59.
Cases with a history of the past of hypersensitivity.
The cases that has difficulty in mutual understanding in self.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiniti Yoshiya |
Organization
Hyogo college of medicine
Division name
Department of Orthropaedic Surgery
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya-city, Hyogo
TEL
0798456452
secret@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maiko Koike |
Organization
Hyogo college of medicine
Division name
Department of Orthropaedic Surgery
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya-city, Hyogo
TEL
0798456452
Homepage URL
secret@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo colleage of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
兵庫医科大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 17 | 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
| 2016 | Year | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 17 | Day |
Last modified on
| 2019 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026185
