UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043708 |
|---|---|
| Receipt number | R000049894 |
| Scientific Title | Ultrasound-Guided Hematoma Block with bupivacaine for the Pain Treatment of rib fracture, Randomized Double-Blind Placebo-Controlled Clinical Trials. |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2021/06/06 11:46:53 |
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Basic information
Public title
Ultrasound-Guided Hematoma Block with bupivacaine for the Pain Treatment of rib fracture, Randomized Double-Blind Placebo-Controlled Clinical Trials.
Acronym
Ultrasound-Guided Hematoma Block for the Pain Treatment of rib fracture.
Scientific Title
Ultrasound-Guided Hematoma Block with bupivacaine for the Pain Treatment of rib fracture, Randomized Double-Blind Placebo-Controlled Clinical Trials.
Scientific Title:Acronym
Ultrasound-Guided Hematoma Block for the Pain Treatment of rib fracture.
Region
| Japan |
Condition
Condition
rib fracture
Classification by specialty
| Orthopedics | Anesthesiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the pain relief effect of hematoma block and placebo for patients with rib fractures.
Basic objectives2
Others
Basic objectives -Others
In patients with rib fractures, the pain and ventilatory function improvement effects of the rib fracture hematoma block group and placebo group should be compared. The amount of additional analgesics to be used and the length of hospitalization should be compared. Efficacy and safety should be compared.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The change over time of the Numerical Rating Scale during body movement from block to 48 hours is compared.
Key secondary outcomes
Changes in respiratory rate and SpO2 values over time from block to 48 hours. Changes in inspired air during blocking and after 24 and 48 hours. NRS 1 hour after block. Amount of additional analgesics used during the first 48 hours. Length of hospital stay for patients with rib fractures alone. The nature and frequency of adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Hematoma block with bupivacaine. The dose of bupivacaine should be 5 ml for 1 rib fracture and 20 ml for each side. Only one intervention is allowed.
Interventions/Control_2
saline placebo group. The normal saline solution should be 5 ml for 1 rib fracture and 20 ml for each side. Only one intervention is allowed.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Persons who have received written consent to participate in a study
2)Men and women aged 20 or older at the time of consent
3)Those who are diagnosed with rib fracture by chest CT.
4)patient who is hospitalized
Key exclusion criteria
1)Persons under ventilator management
2)Those who are taking sedatives.
3)Persons with impaired consciousness who are difficult to evaluate NRS
4)Pregnant or breastfeeding women
5)Those who have a history of hypersensitivity to bupivacaine.
6)Persons taking opioids at the time of consent
7)A person whose NRS during body movement is 3 or less at the time of the next weekday morning round
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Kimura |
Organization
National Center for Global Health and Medicine
Division name
Department of Emergency Medicine and Critical Care
Zip code
1628655
Address
1-21-1 Toyama Shinjyuku-ku Tokyo
TEL
0332027181
akimura@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Momoyo |
| Middle name | |
| Last name | Miyazaki |
Organization
National Center for Global Health and Medicine
Division name
Department of Emergency Medicine and Critical Care
Zip code
1628655
Address
1-21-1 Toyama Shinjyuku-ku Tokyo
TEL
0332027181
Homepage URL
mmiyazaki@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
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
National Center for Global Health and Medicine
Address
1-21-1 Toyama Shinjyuku-ku Tokyo
Tel
0332027181
rinrijm@hosp.ncgm.go.jp
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 01 | 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 | 02 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | 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 | 03 | Month | 22 | Day |
Last modified on
| 2021 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049894
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
