UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020534
Receipt number R000023705
Scientific Title Is interfascial injection approach really compatible with nerve stimulating approach during ultrasound-guided obturator nerve block?
Date of disclosure of the study information 2016/01/12
Last modified on 2016/03/21 12:51:45

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Basic information

Public title

Is interfascial injection approach really compatible with nerve stimulating approach during ultrasound-guided obturator nerve block?

Acronym

ultrasound-guided obturator nerve block

Scientific Title

Is interfascial injection approach really compatible with nerve stimulating approach during ultrasound-guided obturator nerve block?

Scientific Title:Acronym

ultrasound-guided obturator nerve block

Region

Asia(except Japan)


Condition

Condition

bladder cancer

Classification by specialty

Urology Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Transurethral resection of bladder tumor (TURB) has been essential treatment for bladder tumors. Direct electrical stimulation of an obturator nerve (ON) during TURB procedures can trigger an inadvertent adductor muscle spasm, which can cause a serious complication like bladder perforation. Spinal anesthesia with selective obturator nerve block (ONB) can be performed for TURB, however adductor spasm also can be induced because of incomplete ONB. Ultrasound guidance with nerve stimulator has been known to enhance the efficacy of the ONB.
On the other hand, there are some reports that the efficacy of interfascial injection with ultrasound only is similar to the ultrasound guidance with nerve stimulation, which is got through the idea of ON passing through the given pathway; After exiting the obturator canal, the anterior branch has been known to be located within the interfascial layers among adductor longus, adductor brevis, and pectineus muscles, and the posterior branch is located within the interfascial layers between the adductor brevis and adductor magnus muscles at the inguinal crease.
We wonder whether the injection of the fixed-site within the interfascial layers can really cover the exact pathway of ON branches, considering the anatomical variability of ON at the inguinal crease. Therefore, we want to investigate whether interfascial injection is really compatible with nerve stimulator in the ONB.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

success rate of ultrasound-guided obturator nerve block with ultrasound-guided interfascial group (US-IFI group) and ultrasound-guided nerve stimulator group (US-NS group)- Complete ONB will be confirmed with nerve stimulator at the end of the procedure, and if the residual twitching remained, the case is considered to be a 'fail'.
time- after the end of the procedure ONB

Key secondary outcomes

After that, the obturator reflex grade will be checked during TURB by two assistants of urology.
time- right after starting the TURB


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

(US-IFI group;experimental)
ultrasound only (whether ultrasound without nerve stimulator can be enough for obturator block)

duraton: when gathering 31 cases

Interventions/Control_2

(US-NS gorup; active comparator)
nerve stimulator and ultrasound
known method

duration: when gathering 31 cases

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

all patients anticipating TURB with American Society of Anesthesiologists Physical Status (ASA) I or II

Key exclusion criteria

patients with diabetes or peripheral neuropathy, ASA greater than III, coagulation disorders, known allergy to local anesthetics, uncooperative patients and patients' refusal

Target sample size

62


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mi Geum Lee

Organization

Gachon University Gil Medical Center

Division name

Anesthesiology and Pain medicine

Zip code


Address

Namdong-daero 774 beon-gil, Namdong-gu, Incheon 21565 Korea

TEL

82-32-460-3637

Email

mikeum2@gilhospital.com


Public contact

Name of contact person

1st name
Middle name
Last name Mi Geum Lee

Organization

Gachon University Gil Medical Center

Division name

Anesthesiology and Pain Medicine

Zip code


Address

Namdong-daero 774 beon-gil, Namdong-gu, Incheon 21565 Korea

TEL

82-32-460-3637

Homepage URL


Email

mikeum2@gilhospital.com


Sponsor or person

Institute

Gachon University Gil Medical Center

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Non profit foundation

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

Gachon University Gil Medical Center (Incheon)


Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 12 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

2016 Year 01 Month 10 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 20 Day

Last follow-up date


Date of closure to data entry

2016 Year 03 Month 18 Day

Date trial data considered complete


Date analysis concluded

2016 Year 03 Month 21 Day


Other

Other related information



Management information

Registered date

2016 Year 01 Month 12 Day

Last modified on

2016 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023705


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name