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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005673
Receipt No. R000006673
Scientific Title Investigation on the effects of local anesthetic spread during ultrasound-guided subgluteal sciatic nerve block on surgical anesthesia and complications
Date of disclosure of the study information 2011/06/01
Last modified on 2014/03/03

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Basic information
Public title Investigation on the effects of local anesthetic spread during ultrasound-guided subgluteal sciatic nerve block on surgical anesthesia and complications
Acronym Investigation on the effects of local anesthetic spread during ultrasound-guided subgluteal sciatic nerve block on surgical block
Scientific Title Investigation on the effects of local anesthetic spread during ultrasound-guided subgluteal sciatic nerve block on surgical anesthesia and complications
Scientific Title:Acronym Investigation on the effects of local anesthetic spread during ultrasound-guided subgluteal sciatic nerve block on surgical block
Region
Japan

Condition
Condition diseases that require elecive minor knee surgery
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of ultrasound-guided subgluteal sciatic nerve block between single and multiple local anesthetic injection techniques
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Time required for onset of sensory and motor blocks of the sciatic nerve
Key secondary outcomes Quality of analgesia, conversion to general anesthesia and amount of analgesic agent administered during surgery, and postoperative complications.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Local anesthetic agent is injected to get circumferential spread around the sciatic nerve (what is called doughnut sign). The number of needle passes is not limited.
Interventions/Control_2 The number of needle pass is limited to once. Local anesthetic agent is injected to get spread along the dorsal surface of the sciatic nerve.
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
12 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients undergoing monor knee surgery
Key exclusion criteria patients with a history of diabetes mellitus, neurologic disease, infections at the site of injection, and who require general anesthesia.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Sakura
Organization Shimane University, Faculty of Medecine, Univesity hospital
Division name Surgical center
Zip code
Address 89-1 Enya-cho, Izumo City, Simane
TEL 0853-20-2295
Email ssakura@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Sakura
Organization Shimane University, Faculty of medecine, Univesity hospital
Division name Surgical center
Zip code
Address 89-1 Enya-cho, Izumo City, Simane
TEL 0853-20-2295
Homepage URL
Email ssakura@med.shimane-u.ac.jp

Sponsor
Institute Shimane University, Faculty of medecine, Univesity hospital
Institute
Department

Funding Source
Organization Shimane University, Faculty of medecine, Univesity hospital
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
Address
Tel
Email

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 島根大学医学部附属病院(島根県)

Other administrative information
Date of disclosure of the study information
2011 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 Completed
Date of protocol fixation
2011 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
2013 Year 09 Month 30 Day
Date trial data considered complete
2013 Year 12 Month 01 Day
Date analysis concluded
2013 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 05 Month 30 Day
Last modified on
2014 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006673

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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