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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5G1X5
- Mount Sinai Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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
其他名称:
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实验性的: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
其他名称:
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实验性的: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
其他名称:
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实验性的: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
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
患者的充分反应,定义为不要求补充镇痛
大体时间:6个小时
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患者的充分反应,定义为在第一产程完成或程序间歇性硬膜外推注 (PIEB) 开始后 6 小时内不要求补充镇痛(PCEA 推注或临床医生推注)。
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6个小时
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Sensory block level
大体时间: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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
使用 Bromage 评分评估的运动阻滞水平
大体时间:6个小时
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运动阻滞将通过 Bromage 评分进行评估:0 = 能够抬起伸展的腿; 1 = 不能抬起伸直的腿,但可以屈膝; 2 = 无法弯曲膝盖,但可以弯曲脚踝; 3 = 无法弯曲脚踝。
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6个小时
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疼痛评分
大体时间:6个小时
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使用 VNRS 每小时测量一次疼痛评分 (0-10)
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6个小时
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低血压
大体时间:6个小时
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收缩压较基线下降超过 20%(定义为硬膜外麻醉前 3 次读数的平均值)。
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6个小时
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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