Does Use of Ultrasound Reduce the Rate of Sham Caudal Block in Children
調査の概要
詳細な説明
Caudal blocks are one of the most commonly performed regional anesthetics in children and are performed daily for a host of infra-umbilical surgical procedures. A caudal block is an epidural injection, most commonly of local anesthetic into the epidural space as accessed via the sacral hiatus. In children, the sacral hiatus is a normally occurring aperture in which the epidural space may be accessed with extremely minimal risk; as neural tissue ends more proximally. Due to this measure of safety, caudal blocks are preferred in children when compared with standard lumbar epidurals. Caudal blocks are performed blindly using palpation and tactile feedback to assess if the medication is being administered in the correct location. As a result of blind injection, administration of local anesthetic totally or partially outside of the correct site can often be unnoticed or identified after a significant volume has already been injected. With the potential for toxicity of local anesthetic, this may result in either the inability to give a complete dose or an unintentional and often unnoticed sham block "incorrect site of injection".
Use of ultrasound has been proposed for identification of caudal block placement and correct medication spread. However, a recent review of the Pediatric Regional Anesthesia Network database reveals that ultrasound is reportedly only used in less that 3% of blocks. The benefit of ultrasound is safe and real-time confirmation of injection. Ultrasound allows the provider to determine with minimal local anesthetic or even saline injection if the correct space is accessed. Without ultrasound, failed blocks are either identified after significant percentage of the total dose of local anesthetic is incorrectly administered or intra or post operatively when the patient demonstrates a significant opioid requirement. This is problematic given that one of the primary benefits of a caudal block in children is the ability to avoid opioids.
Review of local practice here at Texas Children's Hospital for quality improvement purposes revealed a failure rate of caudal blocks to be 18%. Failure was defined as a heart rate increase with incision of >20% despite a caudal block and >1MAC of gas for the patient age. These patients all required opioids both intra and post operatively in addition to surgical levels of inhaled anesthetic agent.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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Texas
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Houston、Texas、アメリカ、77030
- Texas Childrens Hospital
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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:
- Children ages 0-84 months
- Infra-umbilical procedure for which a caudal block is already planned
- American Society of Anesthesiology classifications of 1,2 or 3
Exclusion Criteria:
- Incarcerated hernias
- Emergency procedures
- Local Anesthetic allergy
- Sacral dimple
- Rash over sacrum
- Parents/legal guardians unable to consent for surgical procedure in English language Foster Care/Child protective services as guardians
- Parental Refusal for caudal block or study participation
- American Society of Anesthesiology classifications other than 1,2 or 3
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:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Ultrasound
The attending anesthesiologist will perform or instruct the placement of a caudal block according to their standard of practice. At the time of administration of local anesthetic into the caudal space, the study collaborator (SC) will ultrasound the caudal space keeping the provider placing the block blinded to the imaging. The provider placing the block will inject 0.5mL of saline. The provider will then be asked to state if they are correctly in the caudal space or not. If the provider feels they are not in the caudal space, they will re-do the procedure. If the provider fails to identify incorrect location and this is noted by ultrasound, the SC will inform the provider to re-do the procedure. All study participants will have ultrasound used for caudal block. |
The attending anesthesiologist will perform or instruct the placement of a caudal block according to their standard of practice.
At the time of administration of local anesthetic into the caudal space, the study collaborator (SC) will ultrasound the caudal space keeping the provider placing the block blinded to the imaging.
The provider placing the block will inject 0.5mL of preservative free saline.
The provider will then be asked to state if they are correctly in the caudal space or not.
If the provider feels they are not in the caudal space, they will re-do the procedure.
If the provider fails to identify incorrect location and this is noted by ultrasound, the SC will inform the provider to re-do the procedure
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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 |
|---|---|---|
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Identify the rate at which blindly placed caudal blocks are not within the epidural space
時間枠:15 minutes
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Assess the percentage of providers not recognizing wrong site of injection without ultrasound
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15 minutes
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Identify the rate at which ultrasound can guide a wrong block into the correct location
時間枠:15 minutes
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Assess the number of blocks that are require the use of ultrasound to redirect needle into caudal space
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15 minutes
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Identify if lack of heart rate change on incision can predict successful placement when medication administration is successfully confirmed with ultrasound
時間枠:15 minutes
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With ultrasound identification of correct caudal injection, (successful block), does lack of heart rate change correlated with successful block
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15 minutes
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Identify if after using ultrasound to visualize placement, if concentrations of inhaled agents may be reduced in children
時間枠:30 minutes to 3 hours
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With demonstration of successful caudal injection, can inhaled agent concentration be reduced as calculated by MAC hours
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30 minutes to 3 hours
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協力者と研究者
捜査官
- 主任研究者:Adam C Adler, MD, FAAP、Texas Childrens Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
- H-40844
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
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