The Relationship Between Local Anesthetic Concentration and Volume on Adequate Labor Analgesia With Programmed Intermittent Epidural Bolus
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Anesthesia Provider Administered Bolus
研究概览
简要总结
Neuraxial labor analgesia is performed by the administration of a local anesthetic/opioid mixture in the epidural space. The delivery method is a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient controlled epidural analgesia [PCEA]) via epidural catheter. The anesthetic solution administered through the lumbar epidural catheter must spread cephalad in the epidural space to reach the T10 nerve roots and spinal cord, and must spread caudad to reach the caudal nerve roots in the epidural space.
Epidural infusion pumps capable of delivering PIEB of local anesthetic with PCEA have become commercially available and many studies have attempted to assess the optimal parameter settings (including volume of programmed bolus, bolus interval, rate of bolus administration) to provide superior labor analgesia.
Traditionally higher concentration local anesthetic solutions have been associated with increased motor blockade leading to a higher incidence of instrumental vaginal delivery. Several local anesthetic solutions with varying drug concentrations are available for labor analgesia and are used clinically in the United States. We plan to perform a randomized, controlled, double-blind study to test the hypothesis that patients whose labor analgesia is maintained using PIEB with low-volume bolus (6.25 mL) of a higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) will require less supplemental analgesia (manual provider re-doses) than patients whose PIEB is delivered with a high-volume bolus (10 mL) of lower density local anesthetic solution (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
The aim of this study is to evaluate the association between bolus volume and concentration of local anesthetic during maintenance of labor analgesia with programmed intermittent epidural bolus (PIEB) analgesia.
The hypothesis of this study is: patients whose labor analgesia is maintained using PIEB with low-volume bolus (6.25 mL) of higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) will have a longer duration of adequate analgesia (time to first manual re-dose request) than patients whose PIEB is delivered with a high-volume bolus (10 mL) of lower concentration local anesthetic solution (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participant and outcomes assessor will be blinded to the assigned randomization.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years and above
- •Nulliparous parturients
- •Present to the labor and delivery unit for an induction of labor or who are in spontaneous labor
- •Request neuraxial labor analgesia at ≤5 cm cervical dilation
排除标准
- •Patients who are not eligible to receive a combined spinal epidural (CSE) technique with 25 mcg of intrathecal fentanyl
- •Non-English speaking
- •Failed initiation of CSE analgesia (VAS pain score >10 15 minutes after intrathecal dose)
- •Need to have the epidural catheter replaced during labor
- •Who deliver within 90 minutes of initiation of labor analgesia
- •Require re-dose within 90 minutes of initiation of labor analgesia.
研究组 & 干预措施
Low volume bolus
6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)
干预措施: Low volume bolus (Drug)
High volume bolus
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
干预措施: High volume bolus (Drug)
结局指标
主要结局
Anesthesia Provider Administered Bolus
时间窗: 72 hours
Anesthesia provider (MD) administered boluses of additional anesthetic administered prior to the delivery of the baby.
次要结局
- VAS at 10 Centimeters Dilation of Cervix(24 hours)
- VAS Score After Delivery(24 hours)
- Intrascapular Pain(72 hours)
- Provider Administered Bolus(72 hours)
- Number of Participants Who Required Additional Provider Redoses(72 hours)
- Time to First Anesthesiology Provider Bolus(72 hours)
- VAS Score Prior to First Provider Bolus Dose(72 hours)
- VAS Score 30 Minutes After Anesthetic Care Provider Dose(72 hours)
- Bupivacaine Consumption Per Hour(72 hours)
- Maximum Oxytocin Dose(72 hours)
- Time of Intrathecal Administration to Delivery(72 hours)
- Number of Participants Categorized by Mode of Delivery(72 hours)
- PCA Boluses(72 hours)
- PCA Boluses Ratio(72 hours)
研究者
Feyce M. Peralta, MD, MS
Principal Investigator
Northwestern University