ESPBの局所麻酔拡大に対する異なる噴射速度
超音波誘導エレクタースピナ平面ブロックの局所麻酔拡大に対する異なる注入率の影響
The aim of this clinical trial is to investigate the effect of different injection speeds on the spread of local anesthetic during ultrasound-guided erector spinae plane block (ESPB) in patients undergoing CT-guided lung nodule localization. The primary question addressed is whether a high injection speed (30 ml delivered within 30 seconds) produces a different local anesthetic distribution compared with a lower injection speed (30 ml delivered within 180 seconds).
調査の概要
詳細な説明
Senventy-four patients were selected to undergo CT guided puncture localization of lung nodules under local anesthesia, and the patients were divided into groups using a computer-generated random number in a ratio of 1:1. To ensure objectivity, a nurse who was not involved in the study prepared a sealed opaque envelope containing grouping information. Patients were randomly divided into two groups: control group (group C, 37 patients), and experimental group (group S, 37 patients). All patients underwent ultrasound guided ESPB before CT-guided nodule localization. Ultrasound guided ESPB method: Using a high-frequency linear probe (5-13 MHz, Sonosite, USA), the probe is placed parallel to the spine on the surface of the transverse process tip of the seventh thoracic vertebrae. Under ultrasound, the transverse process and spinal muscles are clearly exposed. Then, a long beveled needle is used, and inserted from the cephalad to caudal with in-plane technique. After the needle tip reaches between the transverse process and erector spinae muscles, 2ml saline is injected using water separation technique to confirm the position of the needle tip, then injecting 30ml local anesthetic solution (0.75% ropivacaine 15ml+iohexol 15ml). In the control group, the injection is administered at a rate of 30 ml within 180 seconds. In the experimental group, the injection is delivered at a faster rate of 30 ml withinr 30 seconds. After 30 minutes of block completion, CT scan and puncture localization were performed, following with 3D reconstruction. The primary outcome was mixture spread to the paravertebral space.The second outcomes were as follow: 1.spread to the intercostal space. 2. spread to the epidural space 3.spread to the neural foramina 4. cranio-caudal spread
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：Tao Shan
- 電話番号：+8618852095135
- メール：shantao2021@163.com
研究場所
-
-
Jiangsu
-
Nanjing、Jiangsu、中国
- 募集
- Nanjing First Hospital
-
コンタクト：
- YING ZHANG
- 電話番号：025-52271064
-
-
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 scheduled for CT-guided lung nodule localization under local anesthesia will be selected
- aged 18-80 years
- BMI 18-30 kg/m²
- ASA classification I-III
Exclusion Criteria:
- Allergy to the study drug or to local anesthetics
- History of opioid abuse
- Previous infection at the ESPB or PVB puncture site
- Peripheral neuropathy
- Dysfunction of blood coagulation
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Group C
A total of 30 ml of the local anesthetic solution (0.375% ropivacaine, comprising 15 ml ropivacaine and 15 ml iodinated contrast) is injected. In the Group C, the injection is administered within 180 seconds. |
Patients undergoing CT-guided lung nodule localization were selected for the study, and ultrasound-guided erector spinae plane block was performed before surgery with different injection speed. |
|
実験的：Group S
A total of 30 ml of the local anesthetic solution (0.375% ropivacaine, comprising 15 ml ropivacaine and 15 ml iodinated contrast) is injected. In the Group S, the injection is administered within 30 seconds. |
Patients undergoing CT-guided lung nodule localization were selected for the study, and ultrasound-guided erector spinae plane block was performed before surgery with different injection speed. |
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 |
|---|---|---|
|
Spread of local anesthetic into the paravertebral space
時間枠：30 minutes after completion of the ESPB block
|
Observation of local anesthetic spread into the paravertebral space with CT by a researcher who was blinded to group allocation |
30 minutes after completion of the ESPB block
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diffusion of local anesthetic into intercostal space
時間枠：30 minutes after completion of the block
|
The Incidence and thoracic level of local anesthetics to intercostal space was observed with CT by a researcher who was blinded to group allocation. |
30 minutes after completion of the block
|
|
Diffusion of local anesthetic into the epidural space
時間枠：30 minutes after completion of the block
|
Incidence and segment of local anesthetic spread into the epidural was assessed by a researcher who was blinded to group allocationTime Frame: 30 minute after completion of the block |
30 minutes after completion of the block
|
|
Diffusion of local anesthetic into the neural foramina
時間枠：30 minutes after completion of the block
|
Incidence and segment of local anesthetic spread into the neural foramina was assessed by a researcher who was blinded to group allocationTime Frame: 30 minute after completion of the block |
30 minutes after completion of the block
|
|
Cephalocaudal spread of local anesthetic
時間枠：30 minutes after completion of the block
|
Observation of local anesthetic spread cephalocaudally |
30 minutes after completion of the block
|
|
Loss to Cold Sensation of Skin
時間枠：30 minutes after block
|
The sensation to cold was assessed with ice. The area includes the anterior chest wall (midclavicular line), lateral chest wall (posterior axillary line), and posterior chest wall (paraspinal zone) by a researcher who was blinded to group allocation. |
30 minutes after block
|
|
NRS (Numeric Rating Scales) Score
時間枠：1 hour after CT-guided nodule localization
|
Numerical Rating Scale (NRS): This scale is composed of 11 numbers from 0 to 10, with higher numbers indicating greater pain intensity.Patients are required to select a number from 0 to 10 that best represents their current pain intensity based on patients' experience. |
1 hour after CT-guided nodule localization
|
|
Hemodynamic profile
時間枠：Heart rate changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
|
Hemodynamic changes(Heart rate ) during blockade procedure |
Heart rate changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
|
|
Hemodynamic profile
時間枠：Mean arterial pressure changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
|
Hemodynamic changes(Mean arterial pressure ) during blockade procedure |
Mean arterial pressure changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
|
協力者と研究者
捜査官
- スタディチェア：Tao Shan、Nanjing First Hospital, Nanjing Medical University
研究記録日
主要日程の研究
研究開始 (実際)
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
- KY20250327-16
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