Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale(VAS)
研究概览
简要总结
The purpose of this study is to compare the effects of three different doses of hydromorphone combined with ropivacaine and sufentanil combined with ropivacaine in epidural labor analgesia through prospective clinical trials, so as to explore whether hydromorphone combined with ropivacaine has advantages in epidural labor analgesia, and find out the optimal dose of hydromorphone.
Participants will be randomly allocated to four groups: H1 group,H2 group,H3 group and SF group.For those in H1 group: they will be administered with15 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in H2 group: they will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in H3 group: they will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in SF group: they will be administered with 40 ug/ml sufentanil and 0.08% ropivacaine for epidural labor analgesia.
The goal of this clinical trial is to provide a new treatment option for pregnant women in epidural labor analgesia, and to provide a basis for hydromorphone combined with ropivacaine in epidural labor analgesia.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •no contraindication of intraspinal anesthesia the American Society of Anesthesiologists(ASA) physical status ranked Ⅰ-Ⅱ competent to provide informed consent
排除标准
- •poor respiratory functions severe cardiovascular diseases
研究组 & 干预措施
H1 group
H1 group will be administered with15 ug/ml hydromorphone and 0.08% ropivacaine
干预措施: Hydromorphone (Drug)
H1 group
H1 group will be administered with15 ug/ml hydromorphone and 0.08% ropivacaine
干预措施: Ropivacaine (Drug)
H2 group
H2 group will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine
干预措施: Hydromorphone (Drug)
H2 group
H2 group will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine
干预措施: Ropivacaine (Drug)
H3 group
H3 group will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine
干预措施: Hydromorphone (Drug)
H3 group
H3 group will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine
干预措施: Ropivacaine (Drug)
SF group
SF group will be administered with 40 ug/ml sufentanil and 0.08% ropivacaine
干预措施: Sufentanil (Drug)
SF group
SF group will be administered with 40 ug/ml sufentanil and 0.08% ropivacaine
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Visual Analogue Scale(VAS)
时间窗: 30 minutes-1 hour
VAS will be monitored and recorded at 6 time points, including the time of entering the operating room(Time 0), when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), when the first dose is given for 30 minutes(Time 3), 30 minutes after delivery (Time 4), and 60 minutes after delivery (Time 5). The VAS consists of a 10 cm line,with two end points representing 0 (no pain) and 10 (pain as bad as it could possibly be).
次要结局
- Heart rate(HR)(30 minutes-1.5 hours)
- The number of compressions(30 minutes-1.5 hours)
- Duration of analgesia(30 minutes-1.5 hours)
- The Apgar scores(30 minutes-1.5 hours)
- Mean arterial pressure(MAP)(30 minutes-1.5 hours)
- Pulse oxygen saturation(30 minutes-1.5 hours)
- Adverse reactions(30 minutes-1.5 hours)
研究者
Li Na
Deputy Chief Physician
Maternal and Child Health Hospital of Hubei Province