Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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 : Group 1, Group 2, Group 3 and Group 4. For those in Group 1 : they will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 2 : they will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 3 : they will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 4 : they will be administered with 0.4 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
- •American Society of Anesthesiologists (ASA) physical status II
- •a single fetus
- •competent to provide informed consent
排除标准
- •severe respiratory diseases including hypoxemia, respiratory failure and severe pneumonia
- •severe circulatory diseases including acute decompensated heart failure and peripartum cardiomyopathy
- •placenta previa
研究组 & 干预措施
Group 3
Group 3 will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine
干预措施: Hydromorphone (Drug)
Group 1
Group 1 will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine
干预措施: Hydromorphone (Drug)
Group 1
Group 1 will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine
干预措施: Ropivacaine (Drug)
Group 2
Group 2 will be administered with 17.5 ug/ml hydromorphone and 0.08% ropivacaine
干预措施: Hydromorphone (Drug)
Group 2
Group 2 will be administered with 17.5 ug/ml hydromorphone and 0.08% ropivacaine
干预措施: Ropivacaine (Drug)
Group 3
Group 3 will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine
干预措施: Ropivacaine (Drug)
Group 4
Group 4 will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine
干预措施: Sufentanil (Drug)
Group 4
Group 4 will be administered with 0.4 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
- Duration of analgesia(30 minutes-1.5 hours)
- Adverse reactions(30 minutes-1.5 hours)
- Heart rate(HR)(30 minutes-1.5 hours)
- The number of compressions(30 minutes-1.5 hours)
- The Apgar scores(1 minute and 5 minutes after birth)
- Mean arterial pressure(MAP)(30 minutes-1.5 hours)
- Pulse oxygen saturation(30 minutes-1.5 hours)
研究者
Li Na
Deputy Chief Physician
Maternal and Child Health Hospital of Hubei Province