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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043708
Receipt No. 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 2021/03/22

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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
Email 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
Email mmiyazaki@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

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
Email 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 Preinitiation
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 04 Month 15 Day
Last follow-up date
2022 Year 04 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 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049894

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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