Effects of Different Concentrations of Ropivacaine on Prolonged Labor Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) Pain Score
研究概览
简要总结
With the changes in medical models and improvements in people's quality of life, parturients have higher demands for childbirth, making the alleviation and elimination of labor pain an important aspect of modern obstetrics. Intrathecal labor analgesia has been widely adopted in clinical practice to relieve pain. However, current studies mainly focus on parturients who are just beginning to receive labor analgesia, while for those experiencing prolonged analgesia, medical institutions still use traditional formulations, lacking relevant guidelines or expert consensus. In such cases, prolonged waiting and anxiety may lower the pain tolerance of parturients, leading to an increased need for higher concentrations of local anesthetics. To address this clinical gap, this study aims to explore the effects of different concentrations of ropivacaine in prolonged labor analgesia and has designed a prospective randomized controlled trial (RCT) to provide evidence for improving the analgesic regimen for this group of parturients.
详细描述
Background:
With changes in medical models and improvements in quality of life, parturients have higher expectations for childbirth, making the alleviation and elimination of labor pain an important aspect of modern obstetrics. Intrathecal labor analgesia is widely used in clinical practice to relieve labor pain. However, studies on prolonged labor analgesia, especially following the replacement of the first analgesic pump, are scarce. Medical institutions often continue to use traditional analgesic formulations without relevant guidelines or expert consensus. Prolonged analgesia may reduce pain tolerance in parturients, possibly necessitating adjustments in local anesthetic concentration to improve analgesic effectiveness. Given the clinical research gap, this study aims to explore the effects of different concentrations of ropivacaine on prolonged labor analgesia and its impact on maternal and neonatal safety.
Objective:
To investigate the effects and maternal-neonatal safety of using different concentrations of ropivacaine for prolonged labor analgesia, providing clinical evidence for optimizing labor analgesia regimens.
Methods:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A double-blind design is a research method aimed at eliminating bias between participants and researchers. In this design, participants are randomly assigned to different intervention groups (such as different concentrations of ropivacaine), and neither the participants nor the researchers responsible for evaluating the results are aware of the specific group allocations. This ensures the objectivity and reliability of the research findings, avoiding the influence of subjective expectations or observational biases on data interpretation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Singleton pregnancy
- •No contraindications for epidural puncture and voluntarily accepting labor analgesia
- •Maternal participants changing the first pump fluid
排除标准
- •Contraindications for epidural labor analgesia
- •Serious heart, brain, liver, or kidney diseases
- •Mental abnormalities
- •Neurological diseases
- •Maternal request for management of breakthrough pain before changing the pump fluid
研究组 & 干预措施
high concentration ropivacaine group
The combination of 0.12% ropivacaine and 0.5 μg/ml sufentanil
干预措施: High-concentration Ropivacaine (Drug)
Low concentration ropivacaine group.
The combination of 0.1% ropivacaine and 0.5 μg/ml sufentanil
干预措施: Low concentration ropivacaine group (Drug)
结局指标
主要结局
Visual Analog Scale (VAS) Pain Score
时间窗: From pump replacement to the end of labor analgesia.
The pain will be assessed using the Visual Analog Scale (VAS) at four time points: T0 (at the time of pump fluid change) T1 (0.5 hours after the pump fluid change) T2 (1 hour after the pump fluid change) T3 (when full cervical dilation is achieved/in case of emergency cesarean section).
次要结局
- Neonatal Apgar score(10 minutes after the delivery of the fetus)
- nausea and vomiting questionnaire(From pump replacement to the end of labor analgesia.)
- Modified Bromage score(From pump replacement to the end of labor analgesia.)
- Mode of delivery(At the end of delivery)
研究者
Fei Jia
Director of Anesthesiology Department
Chengdu Jinjiang Maternity and Child Health Hospital