UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000038476
Receipt No. R000043775
Scientific Title Effect of nerve block on postoperative outcome
Date of disclosure of the study information 2019/11/02
Last modified on 2019/11/02

* 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 Effect of nerve block on postoperative outcome
Acronym Postoperative effects of nerve block
Scientific Title Effect of nerve block on postoperative outcome
Scientific Title:Acronym Postoperative effects of nerve block
Region
Japan

Condition
Condition Patients who have had lower extremity surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The postoperative pain control in the surgery of the leg is important in carrying out early rising and rehabilitation. The peripheral nerve block is effective for the analgesia in the postoperative early stage, and the use of postoperative opioid can also be reduced.
The purpose of this study was to investigate the effect of nerve block on postoperative outcome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to the first rescue analgesic after surgery
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Orthopedic patients undergoing lower extremity surgery
Key exclusion criteria Patients who do not meet selection criteria
Patients deemed inappropriate by the study director as study subjects
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Ozaki
Organization Tokyo Womens Medical University
Division name Department of Anesthesiology
Zip code 1628666
Address 8-1 Kawadacho Shinjuku-ku Tokyo
TEL 03-3353-8111
Email moz@twmu.ac.jp

Public contact
Name of contact person
1st name Shunsaku
Middle name
Last name Goto
Organization Tokyo Womens Medical University
Division name Department of Anesthesiology
Zip code 1628666
Address 8-1 Kawadacho Shinjuku-ku Tokyo
TEL 03-3353-8111
Homepage URL
Email goto.shunsaku@twmu.ac.jp

Sponsor
Institute Tokyo Womens Medical University
Institute
Department

Funding Source
Organization Tokyo Womens Medical University
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 Tokyo Womens Medical University
Address 8-1 Kawadacho Shinjuku-ku Tokyo
Tel 03-5269-7832
Email rinri.bm@twmu.ac.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
2019 Year 11 Month 02 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 412
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 Main results already published
Date of protocol fixation
2017 Year 07 Month 11 Day
Date of IRB
2017 Year 07 Month 11 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Single-center retrospective observational study
Subjects: Adult patients who underwent lower limb surgery at Tokyo Women's Medical University Hospital between January 1, 2014 and June 30, 2018.
Postoperative outcome in patients with peripheral nerve block

Management information
Registered date
2019 Year 11 Month 02 Day
Last modified on
2019 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043775

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.