UMIN-CTR Clinical Trial

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