Effect of Manipulation of the Programmed Intermittent Bolus Time Interval and Injection Volume on Total Drug Use for Labor Epidural Analgesia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Total Bupivicaine in Milligrams Administered Per Hour of Labor for Analgesia.
研究概览
简要总结
Studies suggest that administration of maintenance epidural solutions as programmed or automated intermittent boluses, rather than continuous infusions, result in lower bupivacaine consumption, decreased need for manual boluses by the anesthesiologist, and greater patient satisfaction. In this technique, the epidural maintenance dose is administered as a bolus by the infusion pump at regular intervals instead of as a continuous infusion. However, the optimal combination of bolus volume and dosing interval has not been determined. At one end of the spectrum, a small volume and short bolus dose interval will likely behave like a continuous infusion. At the other end of the spectrum, a large volume and long bolus dose interval may lead to an increased incidence of breakthrough pain. The purpose of this randomized, double-blind trial was to determine how manipulation of the programmed intermittent time interval and volume influences total drug use, quality of analgesia, and patient satisfaction during maintenance of labor analgesia. We hypothesized that manipulation of the programmed intermittent bolus time interval and volume during the maintenance of epidural labor analgesia influences total drug use, quality of analgesia and patient satisfaction.
详细描述
Traditionally, neuraxial labor analgesia was maintained for the duration of labor with manual intermittent bolus injection of anesthetic by the anesthesiologist via an in-dwelling epidural catheter. During the last decade, there has been a transition to maintenance of analgesia with a continuous epidural infusion. Analgesia is maintained with fewer episodes of breakthrough pain and parturient satisfaction is increased. The anesthesiologists' workload is less. More recently, use of patient controlled epidural analgesia (PCEA) has become popular; usually a continuous infusion is supplemented by patient-activated bolus injections.
Studies have compared the intermittent manual epidural bolus technique to continuous infusion, continuous infusion to PCEA without a background infusion, and PCEA with and without a background infusion. Studies vary in the epidural solution local anesthetic mass (volume and concentration), and lock-out intervals. The incidence and intensity of motor blockade is greater with continuous infusion compared to bolus administration of the same concentration/mass local anesthetic per unit time, whether the bolus is administered manually or by PCEA. Consumption of local anesthetic is less with bolus administration (manual or PCEA) compared to continuous infusion. Therefore, lower concentrations of local anesthetic are frequently used for continuous infusions.
Current pump technology supports continuous epidural infusion, PCEA without a background infusion, and PCEA with a background infusion. Current pump technology does not support programmed intermittent bolus administration with or without supplemental PCEA. Further study in this area may motivate pump manufacturers to redesign their pumps to support this type of drug administration.
The purpose of the study is to determine how manipulation of the programmed intermittent time interval and volume influences total drug use, quality of analgesia, and patient satisfaction during maintenance of labor analgesia.
Eligible women were asked to participate shortly after admission to the Labor and Delivery Unit at Prentice Women's Hospital immediately following the routine preanesthetic interview. Informed, written consent was obtained. At the time of request for labor analgesia the cervix was examined and a baseline Visual Analog Scale (VAS) for pain (100 mm unmarked line with the end points labeled "no pain" and "worst pain imaginable") was determined. Labor analgesia was initiated with a routine combined spinal epidural (CSE) technique. The VAS for pain was determined 10 minutes after the intrathecal injection. If the VAS was less than 10 mm, the parturient was randomized (by a computer generated random number table) to one of three programmed intermittent epidural bolus analgesia maintenance techniques: 2.5 mL every 15 minutes, 5 mL every 30 minutes, or 10 mL every 60 minutes. All epidural solutions consisted of bupivacaine 0.0625% with fentanyl 1.95 micrograms/mL. The initial programmed intermittent bolus dose was initiated 30 minutes after the intrathecal injection in all groups.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •nulliparous women
- •term gestation (greater than or equal to 37 weeks gestation)
- •spontaneous labor or with spontaneous rupture of membranes
排除标准
- •Systemic disease (e.g., diabetes mellitus, hypertension, preeclampsia)
- •use of chronic analgesic medications
- •systemic opioid labor analgesia prior to the initiation of neuraxial labor analgesia
- •cervical dilation less than 2cm or greater than 5cm at time of initiation of neuraxial analgesia
- •delivery within 90 minutes of intrathecal injection
结局指标
主要结局
Total Bupivicaine in Milligrams Administered Per Hour of Labor for Analgesia.
时间窗: From initiation of labor analgesia until delivery less than 24 hours
Total bupivacaine from epidural solution administered for labor analgesia normalized per hour of labor.
次要结局
- Area Under the Visual Analog Pain Scores (0 to 100mm) Per Hour of Labor Analgesia Curve(Duration of labor analgesia)
- Patient Controlled Bolus Attempts(Duration of labor analgesia)
- Number of Patient Controlled Bolus Doses of Bupivacaine/Fentanyl Administered(Duration of labor analgesia)
- Manual Bolus Doses Administered(Duration of labor analgesia)
- Highest Thoracic Dermatome Sensory Level to Ice. Higher Levels Are Given by Lower Thoracic Vertebral Number.(3 hours after initiation of labor analgesia)
- Overall Satisfaction Scores. Higher Scores Represent Greater Satisfaction With Analgesia During Labor and Delivery.(24 hours following labor analgesia)
研究者
Cynthia Wong
Professor of Anesthesiology
Northwestern University
