Intrathecal Hydromorphone for Labor Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Effect on maternal temperature during labor
研究概览
简要总结
The objective of this study is to evaluate the effect of intrathecal hydromorphone on the duration of labor analgesia and the incidence of epidural-associated temperature increase in laboring parturients. We hypothesize that intrathecal administration of longer-acting hydromorphone will:
- Prolong the duration and improve the quality of analgesia in labor, and
- Decrease the incidence of epidural-associated temperature increase in labor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible for enrollment if they are healthy, pregnant females between the ages of 18 and 45 years, primiparous, and at term gestation (≥ 37 weeks).
排除标准
- •Patients with a Category II or III fetal heart rate tracing, a fetus with intrauterine growth restriction, prolonged rupture of membranes, recent diagnosis of infection of any cause, or in whom dural puncture is contraindicated will be excluded from the study.
研究组 & 干预措施
No Hydromorphone
1.7 mg bupivacaine + 17 mcg fentanyl + 0.05 ml of 0.9% normal saline.
干预措施: Hyperbaric bupivacaine (Drug)
No Hydromorphone
1.7 mg bupivacaine + 17 mcg fentanyl + 0.05 ml of 0.9% normal saline.
干预措施: Fentanyl (Drug)
Hydromorphone
1.7 mg bupivacaine + 17 mcg fentanyl + 50 mcg preservative-free hydromorphone (0.05 ml)
干预措施: Hydromorphone (Drug)
Hydromorphone
1.7 mg bupivacaine + 17 mcg fentanyl + 50 mcg preservative-free hydromorphone (0.05 ml)
干预措施: Hyperbaric bupivacaine (Drug)
Hydromorphone
1.7 mg bupivacaine + 17 mcg fentanyl + 50 mcg preservative-free hydromorphone (0.05 ml)
干预措施: Fentanyl (Drug)
结局指标
主要结局
Effect on maternal temperature during labor
时间窗: 2 years
The primary outcome measure will be the incidence of maternal temperature increase, defined as an increase in maternal temperature by 1 degree celsius over the baseline temperature recorded prior to the onset of epidural analgesia.
次要结局
- Effect on efficacy of labor analgesia(2 years)
研究者
Dominique Arce
Instructor of Anaesthesia
Brigham and Women's Hospital