Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia
Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia in Term Parturients Undergoing Elective Caesarian Section- A Randomized Control Trial
Pre-procedural ultrasound for Spinal & Epidural anesthesia is now being increasingly performed worldwide. Pre-procedural ultrasound assessment of the spine has been shown to facilitate the placement of epidural anesthesia in pregnant women, diagnostic lumbar punctures, performance of spinal anesthesia in non-obstetric patients and accurate identification of the interspace at which the puncture is being performed. This is especially important during spinal anesthesia, where puncture below the ending of the spinal cord is recommended for safety.
The purpose of this study is to compare the performance of spinal anesthesia between the pre-procedural ultrasound assessment of the spine and the traditional palpatory technique, in term pregnant women undergoing elective cesarean delivery. Furthermore, we aim to describe sonoanatomic features of the spine that could predict the ease of insertion of spinal anesthesia in that patient population.
We hypothesize that in term pregnant women undergoing elective cesarean delivery, pre-procedural ultrasound assessment of the spine will improve the success rate of spinal anesthesia at first attempt, compared to the traditional palpatory technique.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
Ontario
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Toronto、Ontario、カナダ、M5G1X5
- Mount Sinai 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:
- Pregnant patients scheduled to receive spinal anesthesia for elective cesarean sections
- ASA physical status 1 - 3
- Written informed consent
- Gestational age ≥ 37 weeks.
Exclusion Criteria:
- Patient's refusal.
- Body mass index ≥ 45
- Patient with marked spinal bony deformity (Severe scoliosis on visual inspection and previous spinal instrumentation).
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：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 |
|---|---|
|
介入なし：Palpation
Palpation will be used to determine placement of the spinal needle.
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実験的：Ultrasound
Ultrasound will be used prior to placement of the spinal needle.
|
Ultrasound applied to the lumbar region to determine spinal needle placement.
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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 |
|---|---|---|
|
Spinal needle redirections
時間枠：15 minutes
|
Number of redirections needed to perform a successful spinal puncture (presence of cerebrospinal fluid).
A needle redirection is defined as any change in needle insertion trajectory that did not involve complete withdrawal of the needle from the patient's skin.
The first needle pass will not be considered a redirection.
|
15 minutes
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Needle reinsertions
時間枠：15 minutes
|
Number of needle reinsertions defined as complete withdrawal of the spinal needle to the patient's skin followed by a new attempt in the same interspace.
|
15 minutes
|
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Need to change to another interspace.
時間枠：15 minutes
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Relocating the spinal needle to another interspace.
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15 minutes
|
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Procedure time
時間枠：15 minutes
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Time taken to perform the spinal anesthesia, measured from insertion of the introducer needle to visualization of spinal fluid.
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15 minutes
|
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Pain score
時間枠：15 minutes
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Verbal Numerical Pain Scores during the procedure (0-10, where 0 means no pain and 10 mean the worst pain imaginable).
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15 minutes
|
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Intervertebral level agreement
時間枠：3 hours
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Intervertebral level agreement between L3-L4 obtained in the postoperative ultrasound assessment and the marked intervertebral level obtained pre-procedure, either by ultrasound or palpation.
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3 hours
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Ultrasound Grading
時間枠：3 hours
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Ultrasound Grading: The image pattern of the intervertebral space will be categorized into three grades by three study investigators not involved in providing the spinal anesthesia: Typical Image,Atypical Image or Inconclusive Image.
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3 hours
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協力者と研究者
捜査官
- 主任研究者：Cristian Arzola, MD、Mount Sinai Hospital
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。