Postoperative Dexamethasone on Post-Cesarean Pain in Patients Using Medication Assisted Treatment (MAT)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Mean Pain Score
研究概览
简要总结
Investigating if giving post-operative dexamethasone to patients with a history of opioid use disorder on medication assisted treatment during pregnancy improves their pain scores and decreases their opioid use after cesarean section.
详细描述
For this study, the researchers are most interested in an option that would be able to be administered consistently (same time/same way): that labor nurses could give and without requiring the patient to have had an epidural placement. Further, Gabapentin, clonidine and ketamine are associated with CNS effects like sedation or confusion that could make health care providers less likely to be comfortable giving these women additional oxycodone due to possible worsened sedation or respiratory depression. Lastly, the researchers wanted to give a drug that both obstetricians and pediatricians were comfortable with from extensive use in our maternal population. Thus, a single administration IV dexamethasone was chosen for this study. Dexamethasone has been used as an adjunct for post-operative pain management in many types of surgeries. Although no large randomized trials exist, several small trials suggest an analgesic and opioid sparing effect of dexamethasone post-operatively for both pregnant and non-pregnanat patients; however these studies excluded patients on MAT
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
- Single (Participant)
盲法说明
double blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English-speaking,
- •History of opioid use disorder with current use of MAT during pregnancy,
- •Scheduled for cesarean delivery for their current pregnancy for any indication [examples of elective c-section (decision made for c-section to be performed prior to onset of labor): fetal malpresentation, suspected macrosomia, prior c-section, abnormal placentation, patient preference],
- •Negative toxicology screen upon admission to the hospital for their cesarean section, no prior administration of betamethasone for fetal lung maturity within 24h of their scheduled cesarean delivery
排除标准
- •non-english speaking,
- •screen positive for illicit substance(s) on their admission toxicology screen,
- •require general anesthesia for their cesarean section due to maternal/fetal indication for non-anticipated urgency (thus no longer 'elective') or failure of adequate intra- operative pain control with spinal anesthesia,
- •medical history including known cardiovascular disease, heart failure, uncontrolled hypertension, uncontrolled gestational diabetes or uncontrolled pregestational diabetes, active GI bleed or untreated peptic ulcer,
- •untreated infectious diseases including tuberculosis, systemic candida
研究组 & 干预措施
patients receiving dexamethasone
subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline
干预措施: Dexamethasone (Drug)
placebo
100mL of normal saline (placebo) immediately upon the subjects' arrival to the Post Anesthesia Care Unit (PACU) after leaving the operating room from their scheduled c-section
干预措施: placebo (Other)
结局指标
主要结局
Mean Pain Score
时间窗: 24, 48, 72 and 96 hours post-op
Pain scores via the standardly used and accepted Visual Analog Scale ranging from 1 (lowest) to 10 (highest).
次要结局
- Change of Morphine Use(24, 48 and 72 hours post-op)