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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000022716
受付番号 R000026171
科学的試験名
一般公開日(本登録希望日) 2017/06/30
最終更新日 2019/12/12

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Comparison of classic approach and sub-branch approach during sono-guided obturator nerve block
一般向け試験名略称/Acronym
sono-guided obturator nerve block:sub-branch approach
科学的試験名/Scientific Title
Comparison of classic approach and sub-branch approach during sono-guided obturator nerve block
科学的試験名略称/Scientific Title:Acronym
sono-guided obturator nerve block:sub-branch approach
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
bladder cancer
疾患区分1/Classification by specialty
泌尿器科学/Urology 麻酔科学/Anesthesiology
疾患区分2/Classification by malignancy 悪性腫瘍/Malignancy
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/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.
目的2/Basic objectives2 安全性・有効性/Safety,Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 検証的/Confirmatory
試験の性質2/Trial characteristics_2 説明的/Explanatory
試験のフェーズ/Developmental phase 第Ⅰ相/Phase I

評価/Assessment
主要アウトカム評価項目/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)
副次アウトカム評価項目/Key secondary outcomes


基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding 二重盲検/Double blind -all involved are blinded
コントロール/Control 実薬・標準治療対照/Active
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 予防・検診・検査/Prevention
介入の種類/Type of intervention
医療器具・機器/Device,equipment
介入1/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.

介入2/Interventions/Control_2
Control: classic approach
An anterior and posterior branches block is performed in the same manner with sub-branch block.

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
80 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
all patients anticipating transurethral resection of bladder tumors with American Society of Anesthesiologists physical status(ASA) I or II
除外基準/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
目標参加者数/Target sample size 48

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Mi Geum
ミドルネーム
Lee
所属組織/Organization
Gachon University Gil Medical Center
所属部署/Division name
The Anesthesiology and Pain Medicine
郵便番号/Zip code 21565
住所/Address
Namdong-gaero 774 beon-gil, Namdong-gu, Incheon, 21565, South Korea
電話/TEL 82-32-460-3636
Email/Email mikeum2@gilhospital.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Mi Geum
ミドルネーム
Lee
組織名/Organization
Gachon University Gil Medical Center
部署名/Division name
The Anesthesiology and Pain Medicine
郵便番号/Zip code 21565
住所/Address
Namdong-gaero 774 beon-gil, Namdong-gu, Incheon, 21565, South Korea
電話/TEL 82-32-460-3636
試験のホームページURL/Homepage URL
Email/Email mikeum2@gilhospital.com

実施責任組織/Sponsor
機関名/Institute その他 Gachon University Gil Medical Center
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Gachon University Gil Medical Center
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 財団/Non profit foundation
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
Gachon University Gil Medical Center
住所/Address
Namdong-gaero 774 beon-gil, Namdong-gu, Incheon, 21565, South Korea
電話/Tel 82-32-460-3636
Email/Email mikeum2@gilhospital.com

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2017 06 30

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled 70
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2016 06 13
倫理委員会による承認日/Date of IRB
2016 05 12
登録・組入れ開始(予定)日/Anticipated trial start date
2019 01 17
フォロー終了(予定)日/Last follow-up date
2019 06 10
入力終了(予定)日/Date of closure to data entry
2019 09 16
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2016 06 13
最終更新日/Last modified on
2019 12 12


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000026171
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026171

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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