UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044391 |
|---|---|
| Receipt number | R000050708 |
| Scientific Title | Pericapsular Nerve Group (PENG) Block for Patients with fractured neck of femur in the Emergency Department. A prospective observational study |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2023/10/03 13:36:22 |
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Basic information
Public title
Pericapsular Nerve Group (PENG) Block for Patients with fractured neck of femur. A prospective observational study
Acronym
Pericapsular Nerve Group (PENG) Block for Patients with fractured neck of femur.
Scientific Title
Pericapsular Nerve Group (PENG) Block for Patients with fractured neck of femur in the Emergency Department. A prospective observational study
Scientific Title:Acronym
Pericapsular Nerve Group (PENG) Block for Patients with fractured neck of femur in the Emergency Department.
Region
| Japan |
Condition
Condition
Patients with fractured neck of femur
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm that the PENG block is a effective intervention for an effective intervention for analgesia of patients presenting to the emergency department with fractured neck of femur
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Numetric Rating Scale (NRS) or Pain assessment in Advanced Dementia (PAINAD) are evaluated before and 30,1hr,2hr from pain management. Measured at rest and on movement.
NRS and PAINAD evaluation,from 0(no pain) to 10 (worst pain).
Key secondary outcomes
Duration of pain management.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elder patients ( >65 years )presenting to Tokamachi Hospital Emergency Department with radiologically confirmed neck of femur fractures.
The neck of femur fractures include:
Sub-capital fracture
Surgical neck fracture
Intertrochanteric fracture
Peritrochanteric fracture
Key exclusion criteria
1.Allergy to amide local anaesthesias
2.Infection of the skin site of the potential nerve block
3.The patient has already received a nerve block prior to arrival in emergency department.
4.femoral shaft fracture
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Hida |
Organization
Niigata Prefectural Tokamachi Hospital
Division name
anesthesia department
Zip code
948-0065
Address
3 chome minami , 32-9, takada, tokamachi city, niigata prefecture
TEL
0257575566
seijihida@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Hida |
Organization
Niigata prefectural tokamachi hospital
Division name
anesthesia department
Zip code
948-0065
Address
3 chome minami , 32-9, takada, tokamachi city, niigata prefecture
TEL
0257575566
Homepage URL
seijihida@yahoo.co.jp
Sponsor or person
Institute
Niigata prefectural tokamachi hospital
Institute
Department
Personal name
Funding Source
Organization
Niigata prefectural tokamachi hospital
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 prefectural tokamachi hospital
Address
3 chome minami , 32-9, takada, tokamachi city, niigata prefecture
Tel
0257575566
seijihida@yahoo.co.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
新潟県立十日町病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
32
Results
The pain scores measured at rest were significantly lower at 30mintes but not at 1 hour and 2 hour. Th pain scores at leg movement were significantly lower at 30minute,1 hour and 2hour.
Results date posted
| 2021 | Year | 12 | Month | 01 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
manuscript in preparation
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
Main results already published
Date of protocol fixation
| 2021 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 21 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 17 | Day |
Date analysis concluded
| 2021 | Year | 11 | Month | 24 | Day |
Other
Other related information
Aim
To comfirm that the PENG block is an effective intervention for analgesia of patients presenting to the emergency department with fractured neck of femur.
Assessment
NRS or PAINAD score are evaluated before and 30 minute, 1hr, 2hr from pain management. Measured at rest and on movement.
Design
A prospective observational study
Management information
Registered date
| 2021 | Year | 06 | Month | 01 | Day |
Last modified on
| 2023 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050708
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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