UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044391
Receipt No. 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 2021/06/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email seijihida@yahoo.co.jp

Sponsor
Institute Niigata prefectural tokamachi hospital
Institute
Department

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
Email 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
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
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 11 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2021 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050708

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.