Femoral and Sciatic Nerve Blocks Added to Obturator Nerve Block for Prevention of Obturator Reflex
Comparison of the Efficacy of Femoral and Sciatic Nerve Blocks Added to Obturator Nerve Block in Preventing the Obturator Reflex
This prospective, randomized controlled study aims to evaluate whether adding femoral and sciatic nerve blocks to obturator nerve block improves the prevention of obturator reflex during transurethral resection of bladder tumors under spinal anesthesia.
Ninety patients will be randomly assigned to three groups: obturator nerve block alone, obturator plus femoral nerve blocks, or obturator plus femoral and sciatic nerve blocks. Adductor muscle contractions, surgeon satisfaction, procedure duration, and complications will be evaluated.
調査の概要
状態
詳細な説明
This single-center, prospective, randomized controlled study will include 90 patients aged 18-90 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled for transurethral resection of unilateral lateral bladder wall tumors under spinal anesthesia.
Eligible patients will be randomly allocated into three groups of 30 patients each:
Group 1: Obturator nerve block (ONB) alone.
Group 2: Obturator nerve block combined with femoral nerve block (ONB + FNB).
Group 3: Obturator nerve block combined with femoral and sciatic nerve blocks (ONB + FNB + SNB).
The nerve blocks will be performed using ultrasound guidance according to the study protocol.
During surgery, the occurrence and severity of adductor muscle contractions associated with the obturator reflex will be recorded. Contractions will be classified as absent, mild, or severe according to their interference with the surgical procedure. The total number of contractions will also be documented.
Additional assessments will include block procedure duration, surgical duration, surgeon satisfaction using a 0-10 numerical scale, conversion to general anesthesia, bleeding, bladder injury, perforation, blood transfusion, and complications related to the nerve blocks.
The study aims to determine whether adding femoral and sciatic nerve blocks to obturator nerve block improves the prevention of obturator reflex during transurethral bladder tumor resection.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Tuna Ertürk, MD
- 電話番号：+905325010066
- メール：tunaerturk22@yahoo.com
研究場所
-
-
-
Istanbul、トルコ（Türkiye）、34668
- Sultan 2. Abdulhamid Han Training and Research Hospital
-
コンタクト：
- Hakan EMİRKADI, MD
- 電話番号：+905322609367
- メール：hemirkadi@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients aged 18-90 years.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Patients scheduled for transurethral resection of unilateral lateral or inferolateral bladder wall tumors under spinal anesthesia.
- Patients providing informed consent personally or through a legally authorized representative.
- No known hypersensitivity to the medications used in the study.
- No infection or anatomical deformity at the nerve block sites.
- No antithrombotic treatment and normal coagulation parameters.
Exclusion Criteria:
- Age younger than 18 or older than 90 years.
- ASA physical status IV or higher.
- Absence of informed consent.
- Hypersensitivity to the study medications or their components.
- Infection or anatomical deformity at the nerve block sites.
- Antithrombotic treatment.
- Abnormal coagulation parameters.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Obturator Nerve Block (ONB)
Patients will receive an ultrasound-guided obturator nerve block. |
Ultrasound-guided obturator nerve block will be performed. |
|
実験的：ONB + FNB
Patients will receive ultrasound-guided obturator and femoral nerve blocks. |
Ultrasound-guided obturator nerve block will be performed. Ultrasound-guided femoral nerve block will be performed in addition to obturator nerve block. |
|
実験的：ONB + FNB + SNB
Patients will receive ultrasound-guided obturator, femoral, and sciatic nerve blocks. |
Ultrasound-guided obturator nerve block will be performed. Ultrasound-guided femoral nerve block will be performed in addition to obturator nerve block. Ultrasound-guided sciatic nerve block will be performed in addition to obturator and femoral nerve blocks. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With at Least One Intraoperative Adductor Muscle Contraction
時間枠：On the day of surgery, during transurethral tumor resection
|
Participants experiencing at least one adductor muscle contraction during transurethral bladder tumor resection will be recorded. The number and proportion of affected participants will be compared across the three groups. |
On the day of surgery, during transurethral tumor resection
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Severe Intraoperative Adductor Muscle Contractions
時間枠：On the day of surgery, during transurethral tumor resection
|
Adductor muscle contractions will be classified as severe if they interfere with the surgeon during resection. The number of participants experiencing at least one severe contraction will be recorded and compared across the three groups. |
On the day of surgery, during transurethral tumor resection
|
|
Surgeon Satisfaction Score
時間枠：At the end of surgery, on the day of the procedure
|
Surgeon satisfaction will be assessed using a numerical rating scale from 0 (very poor) to 10 (excellent). Scores will be compared across the three groups. |
At the end of surgery, on the day of the procedure
|
|
Total Number of Intraoperative Adductor Muscle Contractions
時間枠：On the day of surgery, during transurethral tumor resection
|
The total number of adductor muscle contractions occurring during transurethral bladder tumor resection will be recorded for each participant and compared across the three groups. |
On the day of surgery, during transurethral tumor resection
|
|
Number of Participants With Bladder Wall Injury or Perforation
時間枠：On the day of surgery, during transurethral tumor resection
|
The occurrence of bladder wall injury or perforation during transurethral bladder tumor resection will be recorded and compared across the three groups. |
On the day of surgery, during transurethral tumor resection
|
|
Number of Participants With Inability to Continue Surgery Due to Adductor Muscle Contraction
時間枠：On the day of surgery, during transurethral tumor resection
|
Inability to continue surgical resection due to intraoperative adductor muscle contraction will be recorded and compared across the three groups. |
On the day of surgery, during transurethral tumor resection
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Tuna Ertürk, MD、University of Health Sciences Sultan 2. Abdulhamid Han Training and Research Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 20-115
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。