Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: A Sequential Allocation Trial to Determine the Optimum Interval Time Between Boluses of a Fixed Volume of 2.5ml of Bupivacaine 0.25% Plus Fentanyl 8 mcg/ml
Programmed intermittent epidural bolus (PIEB) is a technique of epidural analgesia in which boluses of local anesthetic solutions are injected into the epidural space at a fixed time interval. Despite the increasingly popular use of PIEB for labor analgesia, the optimum regimen of drug delivery has yet to be determined. The outcomes of a chosen regimen will depend on the local anesthetic solution used (drug, concentration and mass) and the parameters established for the PIEB, typically associated with patient controlled epidural analgesia (PCEA). Also, the optimum regimen will depend on the anesthetic and obstetric outcomes of interest.
The investigators have conducted several studies aiming at establishing the optimum PIEB regimen for the patient population at Mount Sinai Hospital. High sensory block levels obtained in some of the previous studies conducted at Mount Sinai Hospital and in other studies in the literature, in spite of not determining adverse effects, suggest an imperfect use of the technique, with an exaggerated and unnecessary spread of the epidural mixture. It is possible that by limiting the spread of the local anesthetic mixture, better analgesia can be provided with less overall consumption of local anesthetic. The investigators wanted to conduct a study using boluses of 2.5 mL of bupivacaine 0.25% with fentanyl 8 mcg/mL. This would maintain the same dose of local anesthetic used in previous studies, but in a much smaller volume. This concentration and volume of bupivacaine has not been tried before as a PIEB regimen.
The hypothesis of this study is that the optimum interval time between PIEB boluses of 2.5 mL of 0.25% bupivacaine plus fentanyl 8 mcg/ml will be between 30 and 60 minutes.
調査の概要
詳細な説明
The investigators have conducted several studies aimed at establishing the optimum PIEB regimen for the patient population at Mount Sinai Hospital. The first study was to determine the effective interval of PIEB in 90% of women during first stage of labor (EI90), while using a fixed bolus of 10 mL of bupivacaine 0.0625% with fentanyl 2 μg/mL. This study showed that the PIEB time interval to provide effective analgesia is approximately 40 minutes, which corresponds to an hourly consumption of 9.4 mg of bupivacaine. In that study, however, 44% of the women experienced sensory blocks to ice above the T6 level (although not associated with motor block or hypotension).
The investigators subsequently conducted another study with the same anesthetic solution and the same PIEB interval of 40 minutes, to determine the effective volume (dose) of local anesthetic to produce the same outcome of effective analgesia without breakthrough pain. The conclusion was that the volume (dose) could not be reduced without compromising efficacy of the technique, and not surprisingly, the sensory block distribution was very similar to that in the first study. The investigators believe that the high sensory block levels obtained the previous studies and in other studies in the literature suggest an imperfect use of the technique, with an exaggerated and unnecessary spread of the epidural mixture. The investigators then conducted a third study to determine the effective time interval between boluses of more concentrated bupivacaine 0.125% 5ml plus fentanyl 2 mcg/ml. The EI90 for boluses of 5ml of bupivacaine 0.125% with fentanyl 2 mcg/mL was found to be approximately 35 minutes. Similar to the two previous studies, the incidence of women exhibiting sensory block to ice >T6 was still high, approximately 58.4%.
This study will further pursue the effect of volume reduction while maintaining the dose of local anesthetic. It may be true that a bolus of 5mL was still too large of a volume to limit the epidural spread. A more limited spread could lead to better usage of the local anesthetic, even reducing its hourly consumption.
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:
- American Society of Anesthesiologists Physical Status II or III
- Full term (greater than or equal to 37 weeks gestation)
- Nulliparous
- Singleton pregnancy, vertex presentation
- Active labor defined as regular painful contractions occurring at 3-5 minutes and with progressive cervical ripening
- Verbal Numerical Pain Score (VNPS) greater than 5 at requesting epidural analgesia (VNPS 0-10)
- Cervical dilatation between 2 and 5 cm
Exclusion Criteria:
- Any contraindication to epidural anesthesia
- Accidental dural puncture
- Allergy or hypersensitivity to bupivacaine or fentanyl
- Use of pharmacological analgesics within the last 4 hours
- Patient refusal to participate in the trial
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：4倍
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：60 minutes
The infusion pump will deliver programmed intermittent epidural boluses at a 60-minute interval.
The bolus will consist of 2.5mL of 0.25% Bupivacaine plus fentanyl 8mcg/ml.
A PCEA bolus of 2.5mL of 0.25% Bupivacaine plus fentanyl 8mcg/ml will also be available.
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0.25% bupivacaine plus fentanyl 8 mcg/ml
他の名前：
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実験的：50 minutes
The infusion pump will deliver programmed intermittent epidural boluses at a 50-minute interval.
The bolus will consist of 2.5mL of 0.25% Bupivacaine plus fentanyl 8mcg/ml.
A PCEA bolus of 2.5mL of 0.25% Bupivacaine plus fentanyl 8mcg/ml will also be available.
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0.25% bupivacaine plus fentanyl 8 mcg/ml
他の名前：
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実験的：40 minutes
The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval.
The bolus will consist of 2.5mL of 0.25% Bupivacaine plus fentanyl 8mcg/ml.
A PCEA bolus of 2.5mL of 0.25% Bupivacaine plus fentanyl 8mcg/ml will also be available.
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0.25% bupivacaine plus fentanyl 8 mcg/ml
他の名前：
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実験的：30 minutes
The infusion pump will deliver programmed intermittent epidural boluses at a 30-minute interval.
The bolus will consist of 2.5mL of 0.25% Bupivacaine plus fentanyl 8mcg/ml.
A PCEA bolus of 2.5mL of 0.25% Bupivacaine plus fentanyl 8mcg/ml will also be available.
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0.25% bupivacaine plus fentanyl 8 mcg/ml
他の名前：
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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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患者の適切な反応。追加の鎮痛を要求しないことと定義される
時間枠：6時間
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患者の適切な反応。分娩の第 1 段階が完了するまで、またはプログラムされた間欠的硬膜外ボーラス (PIEB) の開始後 6 時間まで、追加鎮痛 (PCEA ボーラスまたは臨床医によるボーラス) の要求がないことと定義されます。
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6時間
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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 |
|---|---|---|
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Sensory block level
時間枠：6 hours
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Sensory block to ice will be assessed bilaterally at the mid-clavicular lines, and the level of block will be one level below that where the patient feels as cold as compared to frontal part of the head or cheek
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6 hours
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Bromageスコアを使用して評価されたモーターブロックレベル
時間枠：6時間
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運動ブロックは、ブロマージュ スコアで評価されます。0 = 伸ばした脚を上げることができます。 1 = 伸ばした脚を上げることはできないが、膝を曲げることはできる。 2 = 膝を曲げることはできませんが、足首を曲げることはできます。 3 = 足首を曲げることができない。
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6時間
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痛みのスコア
時間枠：6時間
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VNRS を使用して 1 時間ごとに測定される痛みのスコア (0-10)
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6時間
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低血圧
時間枠：6時間
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ベースラインから 20% を超える収縮期血圧の低下 (硬膜外麻酔前の平均 3 回の測定値として定義)。
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6時間
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協力者と研究者
出版物と役立つリンク
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
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陣痛の臨床試験
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Dexa Medica Group完了