Dexamethasone Administered Via the Epidural Catheter as an Adjunct in Patients Undergoing Cesarean Delivery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pain Scores
研究概览
简要总结
This study will evaluate the ability of dexamethasone to enhance labor epidurals when administered as an adjunct to local anesthetics via an epidural catheter. Patients undergoing elective cesarean sections will be randomized into three groups, each receiving the same combined spinal epidural (CSE). At surgical closure, Group 1 will receive 10cc bupivacaine 0.0625%, Group 2 will receive 10cc bupivacaine 0.0625% +4mg dexamethasone, and Group 3 will receive 10cc bupivacaine 0.0625% + 8mg dexamethasone (4mg). VAS, sedation, nausea, and satisfaction scoring will be measured on patient follow-up to compare the outcomes of the different treatment groups.
详细描述
This study will evaluate the ability of dexamethasone to enhance labor epidurals when administered as an adjunct to local anesthetics via an epidural catheter. Patients undergoing elective cesarean sections will be randomized into three groups using a random allocation table. Group assignment will be performed by opening a previously prepared numbered opaque envelope containing the assignment. Each group will receive the same combined spinal epidural (CSE) containing 10-12mg hyperbaric bupivacaine, 150mcg preservative-free morphine, and 15mcg fentanyl. At surgical closure, Group 1 will receive 10cc bupivacaine 0.0625%, Group 2 will receive 10cc bupivacaine 0.0625% +4mg dexamethasone, and Group 3 will receive 10cc bupivacaine 0.0625% + 8mg dexamethasone (4mg). In order to maintain this as a double-blinded study, the patient will not be told which medication was administered and the drug will be given by one anesthesiologist and the patient follow-up will be performed by a different anesthesiologist. VAS, sedation, nausea, and satisfaction scoring will be measured on patient follow-up to compare how these outcomes compare between the different treatment 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Parturients in their 3rd trimester who are receiving a planned cesarean delivery
- •Primiparous and multiparous pregnancies
- •American Society of Anesthesia (ASA) classes 1, 2 , and 3
排除标准
- •Patients for whom neuraxial anesthesia was either declined, unsuccessful, or contraindicated
- •Gestational Diabetics
- •Diabetics
- •Patients allergic to dexamethasone, local anesthetics, or opioids
- •Patients that are immunosuppressed
- •Patient who received systemic steroids within the preceding 48 hours
研究组 & 干预措施
Placebo
10cc 0.0625% bupivacaine
干预措施: Dexamethasone (Drug)
Low Dose
4mg Dexamethasone + 10cc 0.0625% bupivacaine
干预措施: Dexamethasone (Drug)
Higher Dose
8mg Dexamethasone + 10cc 0.0625% bupivacaine
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Pain Scores
时间窗: up to 48 hours post-op
Visual Analog Scale for Pain, uses the Wong-Baker method of presenting faces with different reactions to pain and scales the patient based on the patient selection of a face. The range goes from 0-10. 0 is pain-free and 10 is excruciating pain.
次要结局
- Sedation Score(up to 48 hours post-op)
- Satisfaction Score(up to 48 hours post-op)
- Nausea/ Vomiting Scale(up to 48 hours post-op)
- Pruritus Score(up to 48 hours post-op)
- Motor Function(up to 48 hours post-op)
研究者
Katherine Nowak
Research Manager
Henry Ford Health System