The Effect of a Single Intraoperative Dose of Dexamethasone in Combination With Intrathecal Morphine for Post Cesarean Delivery Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Postoperative Analgesia
研究概览
简要总结
The purpose of this study is to assess the effectiveness intravenous (IV) dexamethasone when used as part of a multimodal regimen to manage post cesarean delivery pain.
We hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal analgesia after spinal anesthesia will significantly reduce post cesarean delivery opioid consumption and pain
详细描述
After the subjects consent to participate in the study they will be transferred to the operating room for their scheduled cesarean delivery. They will have their routine spinal anesthesia with the dosages of drugs used standardized, and a standardized regimen to manage hypotension. After delivery of the baby the subjects will be administered either the study drug or placebo depending on the randomization. The subjects will then be prescribed a standard post-operative analgesia regimen. The subjects will then be interviewed at 12,24 and 48 hours post cesarean delivery. During the interview the subjects will be asked to rate their pain, nausea and vomiting and pruritus. They will also be asked to rate their quality of recovery from the surgery using Quality of Recovery-40 questionnaire. The subjects will be contacted 6 months after the study to rate their pain using a Short-Form McGill Pain Questionnaire
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English Speaking
- •Non-laboring women
- •Scheduled Elective Cesarean section under spinal anesthesia
- •American Society of Anesthesiologists I-II physical status
排除标准
- •Contraindications to spinal anesthesia
- •allergy to study medication
- •patients with allergy to morphine
- •patients with uncontrolled hypertension
- •history of peptic ulcer disease
- •liver cirrhosis
- •diabetes mellitus
- •known IV drug abusers
- •patients with chronic pain or on long term opioids
- •patients administered steroids in the past week
- •women with fetuses having known congenital abnormalities
- •psychiatric illness such that they are unable to comprehend or participate in study questions
- •patients on antiviral medications or live virus vaccines would also be excluded.
研究组 & 干预措施
Dexamethasone & spinal morphine
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
干预措施: Dexamethasone (Drug)
Placebo injection and spinal morphine
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
干预措施: Placebo (Drug)
结局指标
主要结局
Postoperative Analgesia
时间窗: 24 hours
Comparison of postoperative opioid analgesia use between the 2 groups
次要结局
- Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery(24 hours)
- Quality of Recovery(48 hours)
- Incidence and Severity of Nausea and Pruritus(24 hours)
研究者
Unyime Ituk
Assistant Professor
University of Iowa