Programmed Intermittent Epidural Bolus (PIEB) Compared to Continuous Epidural Infusion (CEI) Relative Efficacy and Mechanism of Efficacy For Labor Anlagesia: A Minimal Local Analgesic Concentration (MLAC) Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Minimum Local Analgesic Concentration (MLAC) of the Final Participants in Each Respective Group at Study Completion
研究概览
简要总结
Utilizing a 'minimal local analgesic concentration (MLAC) study' design to first determine the relative potency of Programmed Intermittent Epidural Bolus (PIEB) compared to Continuous Epidural Infusion (CEI) and secondly to determine the mechanism to explain the potential PIEB efficacy advantage.
详细描述
Pregnant women who present to Labor and Delivery for an anticipated vaginal delivery will be identified as potential participants based on inclusion/exclusion criteria and their desire for labor epidural analgesia. Once identified, interested candidates will be fully informed of the study procedures, have all questions answered, and informed consent obtained. Pregnant participants will receive a labor epidural upon the patient's request and dosed per protocol to adequate analgesic level.
Patients will be randomized into 1 of 4 groups. Either group I or II in Study Part A and group III or IV in Study Part B in a double-blinded design. Each study part will run in parallel and independently.
Each group will have a varying concentration of bupivicaine infusion; continuous or intermittent bolus administration. In addition each group will have continuous or intermittent bolus administration of sufentanil. These concentrations and forms of administration will be blinded to both the patient and study administrator.
Each epidural infusion concentration and continuous or bolus administration will be determined to be a success or failure based on analgesic scores. The investigators' primary outcome will be the minimal local anesthetic concentration of the final participants in each respective group upon study completion.
DATA SAFETY MONITORING PLAN will follow standard of clinical care. Any adverse events will be reported to the PI and necessary adjustments to the protocol will be immediately instituted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA I & II, Nulliparous and Multiparous, Spontaneous/Induced/Augmented Labor, Early active labor (cervix <5 cm (if known)), Pain (VPS) > 3, 18-45 years of age
排除标准
- •<37 weeks gestation, H/o Cesarean Section, Multiple Gestation, Pre-eclampsia, Narcotics within 3 hours prior to labor epidural placement, Chronic Pain (as defined by chronic opiate consumption), Women who are participating in another study that will impact protocol
研究组 & 干预措施
Part A Group 1
CEI bupivacaine and CEI sufentanil
干预措施: Bupivacaine (Drug)
Part A Group 1
CEI bupivacaine and CEI sufentanil
干预措施: Sufentanil (Drug)
Part A Group 2
PIEB bupivacaine and PIEB sufentanil
干预措施: Bupivacaine (Drug)
Part A Group 2
PIEB bupivacaine and PIEB sufentanil
干预措施: Sufentanil (Drug)
Part B Group 3
CEI bupivacaine and PIEB sufentanil
干预措施: Bupivacaine (Drug)
Part B Group 3
CEI bupivacaine and PIEB sufentanil
干预措施: Sufentanil (Drug)
Part B Group 4
PIEB bupivacaine and CEI sufentanil
干预措施: Bupivacaine (Drug)
Part B Group 4
PIEB bupivacaine and CEI sufentanil
干预措施: Sufentanil (Drug)
结局指标
主要结局
Minimum Local Analgesic Concentration (MLAC) of the Final Participants in Each Respective Group at Study Completion
时间窗: From initial epidural bolus to delivery (up to approximately 16 hours)
The mean concentration of Bupivacaine in patients who have success or failure outcome were compared between groups.
次要结局
- Protocol Success or Failure(From initial epidural bolus to delivery (up to 16 hours following initial bolus))
- Time to First Clinician Rescue Analgesia Request (From Initial Epidural Dose)(From initial epidural bolus to delivery (up to 16 hours following initial bolus))
- Numerical Verbal Pain Scores(Patients were assessed once between initial epidural bolus to delivery (up to 16 hours following initial bolus))
- Number of Participants Requiring Treatment for Pruritus, Nausea and Vomiting, or Hypotension(From initial epidural bolus to delivery (up to 16 hours following initial bolus))
- Number of Participants With Maternal Nausea/Vomiting(From initial epidural bolus to delivery (up to 16 hours following initial bolus))
- Patient Satisfaction With Labor Analgesia(Participants were assessed once from initial epidural bolus to delivery (up to approximately 16 hours))
- Labor Outcome (Spontaneous, Assisted, Cesarean)(At the time of delivery)
研究者
Brendan Carvalho
Chief, Division of Obstetric Anesthesia Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine
Stanford University