UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005673
Receipt number 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 14:31:58

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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 or person

Institute

Shimane University, Faculty of medecine, Univesity hospital

Institute

Department

Personal name



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

Value
https://center6.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