A Prospective, Randomized Analysis of Epidural Anesthesia Using Programmed Intermittent Epidural Boluses Versus Continuous Epidural Infusion in Patients Undergoing Abdominal Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Total Local Anesthetic Utilized in First 24 Hours
研究概览
简要总结
Epidurals are an effective means for providing neuraxial anesthesia and analgesia. Prior studies in labor epidurals have demonstrated that a programmed intermittent bolus application of local anesthesia can improve pain control by reducing the amount of local anesthetic required as well as improve patient satisfaction when compared to continuous epidural infusions. The effects of programmed intermittent bolus of epidural local anesthetics compared to continuous epidural infusions in a surgical setting have yet to be elucidated. Our goal is to evaluate the use of programmed intermittent bolus compared to continuous epidural infusion in a surgical patient population. We plan to enroll patients already undergoing abdominal surgeries including colorectal, gynecologic, surgical oncology, urological where epidural anesthesia can be employed. The primary endpoints of the study will be the total local anesthetic consumption and total opioid consumption as surrogate markers for the quality of epidural anesthesia. Secondary endpoints are pain scores and functional measurements, patient satisfaction, and incidence of hypotension.
详细描述
See brief summary
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesia physical classification I - III, scheduled for surgery with anticipated an epidural anesthesia (including but not limited to colorectal, surgical oncology, urology, gynecology) as part of their perioperative treatment
排除标准
- •Age younger than 18 years of age, non-English speaking, contraindication for neuraxial anesthesia (such as, but not limited to coagulopathy, infection at site, allergy to local anesthetic), preexisting neurologic deficits, inability to consent due to cognitive dysfunction, patients with pain numeric rating score > 5 each day for greater than 3 months, daily opioid consumption > 100 oral morphine equivalents for 14 consecutive days prior to surgery, patient refusal.
研究组 & 干预措施
Continuous epidural infusion
At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
干预措施: Bupivacaine (Drug)
Continuous epidural infusion
At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
干预措施: Fentanyl (Drug)
Programmed intermittent epidural bolus
For the programmed intermittent epidural bolus group:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
干预措施: Bupivacaine (Drug)
Programmed intermittent epidural bolus
For the programmed intermittent epidural bolus group:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Total Local Anesthetic Utilized in First 24 Hours
时间窗: In first 24 hours
Total local anesthetic consumed while epidural in place, recorded on infusion pump
次要结局
- Total Opioid Consumed(While epidural in place (up to 72 hours post operatively))
- Worst Reported 24 Hour Pain(While epidural in place (up to 72 hours postoperatively))
- Patient Satisfaction Score(While epidural in place (up to 72 hours postoperatively))
- Average Pain Severity(While epidural in place (up to 72 hours postoperatively))
- Incidence of Hypotension(While epidural in place (24 hours postoperatively))
- Average Pain Interference(While epidural in place (up to 72 hours postoperatively))