UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022716
Receipt number R000026171
Scientific Title Comparison of classic approach and sub-branch approach during sono-guided obturator nerve block
Date of disclosure of the study information 2017/06/30
Last modified on 2019/12/12 16:04:35

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Basic information

Public title

Comparison of classic approach and sub-branch approach during sono-guided obturator nerve block

Acronym

sono-guided obturator nerve block:sub-branch approach

Scientific Title

Comparison of classic approach and sub-branch approach during sono-guided obturator nerve block

Scientific Title:Acronym

sono-guided obturator nerve block:sub-branch approach

Region

Asia(except Japan)


Condition

Condition

bladder cancer

Classification by specialty

Urology Anesthesiology

Classification by malignancy

Malignancy

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 an excellent anesthesia for TURB.
Basically, ON has been known to be divided into two branches after exiting the obturator canal. The anterior branch is located in the fascial planes among adductor longus, adductor brevis, and pectineus muscles, and the posterior branch is located between the adductor brevis and adductor magnus muscles at the inguinal crease. Therefore, ONB has been performed with anterior or posterior (main) branch block at the inguinal crease level. But we became discovered that adductor muscle spasm can occur even in complete main branches block state through our experiences (complete main branches block was confirmed with nerve stimulator).
The main branch of ON has a multiple branching pattern, and subdivisions are extensively distributed among the adductor muscles. Therefore, we suppose that unblocked sub-branches can cause the adductor muscle spasm, even after main branches block. So we suppose that sub-branch block added with main branches block can increase efficacy of classic ONB at the inguinal crease. Incomplete ONB can result into serious bladder perforation, and it is enough damage to patient even in one case. So sub-branch approach can also increase safety of patients.
We chose the fan-like injection technique for blocking the subdivisions, which might be located through the adductor longus, brevis, magnus, pectineus muscles or another point of fascias where main branches pass through. We called it as sub-branch approach of the ONB.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

success rate of sono-guided ONB with classic approach and sub-branch approach (evaluation periods: about 6 months)- obturator reflex grade(I-IV)

Key secondary outcomes



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

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Interventions: sub-branch approach
A 22-gauge, 120-mm stimulating needle (Stimuplex insulated needle; D Plus B. Braun, Melsungen, Germany) attached to a nerve stimulator (Stimuplex HNS12; B. Braun, Melsungen, Germany) is advanced using an ultrasound in-plane approach from lateral to medial to position the needle tip at the fascia of posterior branch. The neurostimulation current starts at 0.5 mA. If adductor muscle twitching is observed even at 0.3 mA, 10 ml of local anesthetic (LA; 1.5% lidocaine + epinephrine 1:200,000) is slowly injected after negative aspiration, and we identify the separation of the adjacent muscles. The needle is then positioned at the fascia of anterior branch, and 10 ml of LA is injected in the same manner. 15 min. After main branches block, the needle is re-advanced fan-likely (needling at least 3 more times) to search for sub-branch of ON (2.0 mA). If twitching is observed on ultrasound view (0.3 - 0.5 mA), 3 ml of LA is injected.

Interventions/Control_2

Control: classic approach
An anterior and posterior branches block is performed in the same manner with sub-branch 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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

all patients anticipating transurethral resection of bladder tumors with American Society of Anesthesiologists physical status(ASA) I or II

Key exclusion criteria

patients with diabetes or peripheral neuropathy; motor or sensory deficits in the lower extremities, ASA greater than III, coagulation disorders, anticoagulant medication, known allergy to local anesthetics, contraindications for spinal anesthesia (infection at injection site, severe scoliosis or fusion operation), uncooperative patients and patients' refusal

Target sample size

48


Research contact person

Name of lead principal investigator

1st name Mi Geum
Middle name
Last name Lee

Organization

Gachon University Gil Medical Center

Division name

The Anesthesiology and Pain Medicine

Zip code

21565

Address

Namdong-gaero 774 beon-gil, Namdong-gu, Incheon, 21565, South Korea

TEL

82-32-460-3636

Email

mikeum2@gilhospital.com


Public contact

Name of contact person

1st name Mi Geum
Middle name
Last name Lee

Organization

Gachon University Gil Medical Center

Division name

The Anesthesiology and Pain Medicine

Zip code

21565

Address

Namdong-gaero 774 beon-gil, Namdong-gu, Incheon, 21565, South Korea

TEL

82-32-460-3636

Homepage URL


Email

mikeum2@gilhospital.com


Sponsor or person

Institute

Gachon University Gil Medical Center

Institute

Department

Personal name



Funding Source

Organization

Gachon University Gil Medical Center

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

Gachon University Gil Medical Center

Address

Namdong-gaero 774 beon-gil, Namdong-gu, Incheon, 21565, South Korea

Tel

82-32-460-3636

Email

mikeum2@gilhospital.com


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 06 Month 30 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

70

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 06 Month 13 Day

Date of IRB

2016 Year 05 Month 12 Day

Anticipated trial start date

2019 Year 01 Month 17 Day

Last follow-up date

2019 Year 06 Month 10 Day

Date of closure to data entry

2019 Year 09 Month 16 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 13 Day

Last modified on

2019 Year 12 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026171


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name