UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028930
Receipt number R000033106
Scientific Title Analgesic effects of sciatic nerve blockade with additional of dexamethasone to local anesthetic: a prospective randomized controlled study in patients after anterior cruise ligament reconstruction surgery
Date of disclosure of the study information 2017/09/04
Last modified on 2018/06/07 15:36:36

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Basic information

Public title

Analgesic effects of sciatic nerve blockade with additional of dexamethasone to local anesthetic: a prospective randomized controlled study in patients after anterior cruise ligament reconstruction surgery

Acronym

Analgesic effects of sciatic nerve blockade with additional of dexamethasone to local anesthetic: a prospective randomized controlled study in patients after anterior cruise ligament reconstruction surgery

Scientific Title

Analgesic effects of sciatic nerve blockade with additional of dexamethasone to local anesthetic: a prospective randomized controlled study in patients after anterior cruise ligament reconstruction surgery

Scientific Title:Acronym

Analgesic effects of sciatic nerve blockade with additional of dexamethasone to local anesthetic: a prospective randomized controlled study in patients after anterior cruise ligament reconstruction surgery

Region

Japan


Condition

Condition

Anterior cruciate ligament injury

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the analgesic effects of additional of a small amount of dexamethasone to local anesthetic for sciatic nerve block in patients after anterior cruciate ligament reconstruction surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time from block to patients feel pain

Key secondary outcomes

Visual analogue pain scores at rest and while movement at 24, 48h after operation
Maxium pain score and the time after block
Time from block to recovery of the motion of the ankle joint
Time when the patients used analgesics
Neurological involvement
Troubles related to catheter


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Additional of dexamethasone 3.3 mg to local anesthetics used for sciatic nerve block

Interventions/Control_2

Only local anesthetics are used for sciatic nerve block

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who schedulled for anterior cruciate ligament reconstruction surgery under peripheral nerve blocks
American Society of Anesthesiologists physical status 1-2

Key exclusion criteria

Neuropathy on the surgical site
Preoperative use of opiate analgesics
Allergy to medications used for study

Target sample size

22


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi Sakura

Organization

Shimane University Hospital

Division name

Operation department

Zip code


Address

89-1 Ennyacho, Izumo-city, Shimane, Japan

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 Hospital

Division name

Operation department

Zip code


Address

89-1 Ennyacho, Izumo-city, Shimane, Japan

TEL

0853-20-2295

Homepage URL


Email

ssakura@med.shimane-u.ac.jp


Sponsor or person

Institute

Shimane University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

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



Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 04 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

The addition of dexamethasone 3.3mg perineural to subgluteal SNB using 0.5% ropivacaine prolonged the duration of sensory and motor blockade in patients undergoing anterior cruciate ligament reconstruction. No complication was observed.

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

2017 Year 08 Month 28 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 04 Day

Last follow-up date

2018 Year 06 Month 07 Day

Date of closure to data entry

2018 Year 06 Month 07 Day

Date trial data considered complete

2018 Year 06 Month 07 Day

Date analysis concluded

2018 Year 06 Month 07 Day


Other

Other related information



Management information

Registered date

2017 Year 08 Month 31 Day

Last modified on

2018 Year 06 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033106


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name