Efficacy and Safety of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia Study: a Randomized, Double-blind, Controlled, Multicenter, Noninferiority Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 356
- 主要终点
- Percentage of effective analgesia
研究概览
简要总结
Women requiring epidural labor analgesia were randomized into two groups, one with the local anesthetic chloroprocaine and the other with ropivacaine. The primary outcome was to observe the analgesic scores of the two groups of drugs as well as adverse reactions.
详细描述
Mothers who met the study criteria vertebrae were included and then divided into two groups. Labor analgesia was provided by epidural anesthesia with a low concentration of local anesthetic (chloroprocaine or ropivacaine) combined with sufentanil. Data related to labor analgesia such as pain scores, motor tissue scores, and body temperature were collected and statistically analyzed to compare the efficacy and adverse effects of the two local anesthetics and to draw conclusions.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primigravid women with full-term pregnancies scheduled for labor analgesia
- •Determination of labor onset to cervical dilatation ≤ 5cm;
- •Visual analogue scale (VAS) pain score during contractions >50 mm (0 mm = no pain at all, 100 mm = most intense pain);
- •Age ≥20 years;
- •American Society of Anesthesiologists (ASA) classification II
- •Body mass index (BMI) between 18.5 and 30 kg/m2
- •Height >155 cm
- •Signed informed consent.
排除标准
- •Twin or multiple pregnancies
- •Hypertension
- •Severe cardiopulmonary and hepatic or renal disease
- •Severe pregnancy comorbidities such as preeclampsia, eclampsia, HELLP syndrome, placenta praevia, placental abruption, etc.
- •Cephalopelvic disproportion
- •History of allergy to local anesthesia
- •Spinal deformity
- •Contraindications to intrathecal anesthesia
- •Refusal to participate in the stud
研究组 & 干预措施
Chloroprocaine group
Selection of local anesthetics for epidural labor analgesia with low concentration of chloroprocaine combined with sufentanil
干预措施: Chloroprocaine (Drug)
Ropivacaine group
Selection of local anesthetics for epidural labor analgesia with low concentration of ropivacaine combined with sufentanil
干预措施: Chloroprocaine (Drug)
结局指标
主要结局
Percentage of effective analgesia
时间窗: 30 min after the first epidural addition at the beginning of labor analgesia
Percentage of effective analgesia within 30 min after the first epidural addition at the beginning of labor analgesia in both groups
次要结局
未报告次要终点