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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 UMIN000026873
受付番号 R000030831
科学的試験名 ペインクリニック・緩和ケアにおける画像ガイド下神経ブロック法の有用性に関する臨床研究
一般公開日(本登録希望日) 2017/04/10
最終更新日 2021/04/08

※ 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 ペインクリニック・緩和ケアにおける画像ガイド下神経ブロック法の有用性に関する臨床研究 Clinical evaluation of image-guided nerve block in pain therapy.
一般向け試験名略称/Acronym 神経ブロック臨床研究 clinical evaluation of nerve block
科学的試験名/Scientific Title ペインクリニック・緩和ケアにおける画像ガイド下神経ブロック法の有用性に関する臨床研究 Clinical evaluation of image-guided nerve block in pain therapy.
科学的試験名略称/Scientific Title:Acronym 神経ブロック臨床研究 clinical evaluation of nerve block
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 難治痛,慢性痛,がん性痛 refractory pain, chronic pain, cancer pain
疾患区分1/Classification by specialty
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 ペインクリニック・緩和ケアにおける画像ガイド下神経ブロック法の有用性を明らかにする to evaluate of image-guided nerve block in pain therapy and palliative care
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
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes ペインクリニック・緩和ケアにおける画像ガイド下神経ブロック法の効果の確実性と合併症回避の安全性を検討する。評価項目は
超音波およびCT画像の視認性、末梢血流変化、サーモグラフィーによる皮膚温変化、出血反応、神経刺激反応、神経ブロックの効果範囲、ブロック前後の痛みの変化、ブロックによる効果の持続期間、治療に対する患者の満足度、生活の質に関わる満足度(睡眠、摂食状況)
imaging of ultrasound or CT, peripheral circulation, skin temperature, nerve block area, duration of the effect, pain score, satisfaction of QOL
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 単群/Single arm
ランダム化/Randomization 非ランダム化/Non-randomized
ランダム化の単位/Randomization unit
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 無対照/Uncontrolled
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 1
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
手技/Maneuver
介入1/Interventions/Control_1 痛みの治療としての神経ブロックを行う。超音波ガイド下やCTガイド下で画像ガイド下に行う。介入の回数は1回から数回である。神経ブロックを行う日数は1回あたり1日である。 nerve block for pain therapy, under imaging guidance of ultrasound or CT, times of intervention: 1 ~ several times, one nerve block in a day,
介入2/Interventions/Control_2

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

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria 神経ブロック治療が必要とされる成人患者
神経ブロックの禁忌がないこと
adult patients need nerve block therapy
nothing of contraindication for nerve block
除外基準/Key exclusion criteria 未成年患者
神経ブロックの禁忌
under adult aged patients
contraindication for nerve block
目標参加者数/Target sample size 150

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
洋司
ミドルネーム
齊藤
Yoji
ミドルネーム
Yoji
所属組織/Organization 島根大学医学部 Shimane University Faculty of Medicine
所属部署/Division name 麻酔科学講座 Department of Anesthesiology
郵便番号/Zip code 693-8501
住所/Address 出雲市塩冶町89-1 89-1, Enya-cho, Izumi
電話/TEL 0853-20-2295
Email/Email ysaito@shimane-u.med.ac.jp

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
俊彦
ミドルネーム
中谷
Toshihiko
ミドルネーム
Nakatani
組織名/Organization 島根大学医学部 Shimane University Faculty of Medicine
部署名/Division name 緩和ケア講座 Department of Palliative Care
郵便番号/Zip code 693-8501
住所/Address 出雲市塩冶町89-1 89-1, Enya-cho, Izumi
電話/TEL 0853-20-2237
試験のホームページURL/Homepage URL
Email/Email tnktn@med.shimane-u.ac.jp

実施責任組織/Sponsor
機関名/Institute その他 Shimane University Faculty of Medicine
機関名/Institute
(機関選択不可の場合)
島根大学医学部
部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Shimane University Faculty of Medicine
機関名/Organization
(機関選択不可の場合)
島根大学医学部
組織名/Division
組織の区分/Category of Funding Organization その他/Other
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 島根大学医学部附属病院臨床研究センター clinical research center
住所/Address 出雲市塩冶町89-1 enya-cho, Izumo
電話/Tel 0853-20-2111
Email/Email kenkyu@med.shimane-u.ac.jp

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 04 10

関連情報/Related information
プロトコル掲載URL/URL releasing protocol https://www.dovepress.com/journal-of-pain-research-journal
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 https://www.dovepress.com/journal-of-pain-research-journal
組み入れ参加者数/Number of participants that the trial has enrolled 9
主な結果/Results Elevation in temperature: by over 1 (sympathetic block, n = 62) and by less than 1 (non-sympathetic block, n = 27). Finger blood flow decreased significantly just after a change in posture after SGB in both groups. In the sympathetic block group, the ratio of finger blood flow in the long sitting position / supine position with a change in posture significantly increased after SGB compared with before SGB (before SGB: range 0.09-0.94, median 0.53, after SGB: range 0.33-1.2, median 0.89, p < 0.0001). Evation in temperature: by over 1 (sympathetic block, n = 62) and by less than 1 (non-sympathetic block, n = 27). Finger blood flow decreased significantly just after a change in posture after SGB in both groups. In the sympathetic block group, the ratio of finger blood flow in the long sitting position / supine position with a change in posture significantly increased after SGB compared with before SGB (before SGB: range 0.09-0.94, median 0.53, after SGB: range 0.33-1.2, median 0.89, p < 0.0001).
主な結果入力日/Results date posted
2021 04 08
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 Nine patients, 5 males and 4 females, aged 44-80 years (mean age 62.3 years, standard deviation 13.3), required treatment by stellate ganglion block. The diagnoses were herpes zoster pain in seven of the patients, tinnitus in one patient, and upper limb pain in one patient. The patients had no history of orthostatic intolerance, such as orthostatic hypotension and related diseases affecting the sympathetic nervous system, or disordered circulation in the upper limb, and were not on prescription vasoactive, cardiac or sweating related medication. Nine patients, 5 males and 4 females, aged 44-80 years (mean age 62.3 years, standard deviation 13.3), required treatment by stellate ganglion block. The diagnoses were herpes zoster pain in seven of the patients, tinnitus in one patient, and upper limb pain in one patient. The patients had no history of orthostatic intolerance, such as orthostatic hypotension and related diseases affecting the sympathetic nervous system, or disordered circulation in the upper limb, and were not on prescription vasoactive, cardiac or sweating related medication.
参加者の流れ/Participant flow Nine patients, 5 males and 4 females, aged 44-80 years (mean age 62.3 years, standard deviation 13.3), required treatment by stellate ganglion block. The diagnoses were herpes zoster pain in seven of the patients, tinnitus in one patient, and upper limb pain in one patient. The patients had no history of orthostatic intolerance, such as orthostatic hypotension and related diseases affecting the sympathetic nervous system, or disordered circulation in the upper limb, and were not on prescription vasoactive, cardiac or sweating related medication. Nine patients, 5 males and 4 females, aged 44-80 years (mean age 62.3 years, standard deviation 13.3), required treatment by stellate ganglion block. The diagnoses were herpes zoster pain in seven of the patients, tinnitus in one patient, and upper limb pain in one patient. The patients had no history of orthostatic intolerance, such as orthostatic hypotension and related diseases affecting the sympathetic nervous system, or disordered circulation in the upper limb, and were not on prescription vasoactive, cardiac or sweating related medication.
有害事象/Adverse events none none
評価項目/Outcome measures 1. Horner’s sign. After SGB, we checked for the presence of myosis, ptosis and enophthalmos. This was assessed to identify successful block of the cervical sympathetic trunk.
2. Presence of brachial nerve block, to exclude sympathetic block in the upper limb due to inadvertent brachial plexus block. In patients in whom it did occur, a significant increase in blood flow to the fingers of the blocked hand was observed throughout the period of brachial plexus anesthesia.4 We checked the presence of brachial nerve block or not.
3. Skin temperature of the thumb on the blocked side by thermography before SGB and 20 min after SGB. An indicator of sympathetic block in the upper limb is elevated skin temperature of over 1 relative to before SGB.5
4. Blood flow in the ball of the thumb on the SGB side. This was measured using a laser blood flow meter (Laser Doppler ALF 21D, ADMEDIC Co. Ltd., Japan) in the supine position and immediately after changing to the long sitting position (the lowest finger blood flow), before SGB and 20 min after SGB.
1. Horner sign. After SGB, we checked for the presence of myosis, ptosis and enophthalmos. This was assessed to identify successful block of the cervical sympathetic trunk.
2. Presence of brachial nerve block, to exclude sympathetic block in the upper limb due to inadvertent brachial plexus block. In patients in whom it did occur, a significant increase in blood flow to the fingers of the blocked hand was observed throughout the period of brachial plexus anesthesia.4 We checked the presence of brachial nerve block or not.
3. Skin temperature of the thumb on the blocked side by thermography before SGB and 20 min after SGB. An indicator of sympathetic block in the upper limb is elevated skin temperature of over 1 relative to before SGB.
4. Blood flow in the ball of the thumb on the SGB side. This was measured using a laser blood flow meter (Laser Doppler ALF 21D, ADMEDIC Co. Ltd., Japan) in the supine position and immediately after changing to the long sitting position (the lowest finger blood flow), before SGB and 20 min after SGB.
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
2017 04 05
倫理委員会による承認日/Date of IRB
2013 03 06
登録・組入れ開始(予定)日/Anticipated trial start date
2017 04 10
フォロー終了(予定)日/Last follow-up date
2018 03 31
入力終了(予定)日/Date of closure to data entry
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
2017 04 05
最終更新日/Last modified on
2021 04 08


閲覧ページへのリンク/Link to view the page
URL(日本語) https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000030831
URL(英語) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030831

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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