Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Pain Scores
研究概览
简要总结
The purpose of this study is to determine if intrathecal hydromorphone will relieve pain as well as intrathecal morphine after cesarean delivery, with fewer side effects.
详细描述
Intrathecal morphine has long been the standard pain medication used in cesarean sections. Since some patients cannot tolerate morphine, hydromorphone may be an acceptable alternative. Intrathecal Intrathecal hydromorphone has been shown to be effective at treating post cesarean section pain and possibly with less side effects than morphine.
One side effect of morphine is respiratory depression occurring hours after the start of morphine use. Respiratory depression occurs when air being taken into the lungs is less than normal, leading to a lower amount of oxygen and carbon dioxide being exchanged in the blood stream. Because hydromorphone dosages are lower and it has a quicker onset of action than morphine, it is believed that the use of hydromorphone should decrease the possibility of delayed respiratory depression.
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 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Scheduled for elective Cesarean sections under spinal anesthesia or combined spinal anesthesia
- •ASA status of I-III
- •BMI < 40
- •Able to understand and sign informed consent
排除标准
- •Severe pre-eclampsia
- •Conversion to general anesthetic
- •History of chronic opioid use
- •Allergy to morphine, or hydromorphone
- •Hyperemesis gravidarum
- •Emergency case
- •Patients who have an infection at the intended site of spinal insertion
研究组 & 干预措施
Hydromorphone
100 mg, intrathecal administration
干预措施: Hydromorphone (Drug)
Morphine
200 mg, intrathecal administration
干预措施: Morphine (Drug)
结局指标
主要结局
Change in Pain Scores
时间窗: from Baseline to 24 Hours
Pain scores to be measured using the verbal response scale (VRS). The VRS pain score is measured on a scale of 0-10 with 0 representing absolutely no pain and 10 representing worst pain imaginable
次要结局
- Number of Participants with Adverse Events (AEs)(up to 24 Hours)
研究者
Grace Shih, MD
Associate Professor
University of Kansas Medical Center
