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临床试验/NCT01866254
NCT01866254已完成早期 1 期

Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries

Grace Shih, MD1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

100 mg, intrathecal administration

干预措施: Hydromorphone (Drug)

Morphine

Active Comparator

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

发起方
Grace Shih, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Grace Shih, MD

Associate Professor

University of Kansas Medical Center

研究点 (1)

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