The Effect of Dural Puncture Epidural Block Technique on the Effectiveness and Safety of Labor Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The incidence of NICHD category elevation from baseline
研究概览
简要总结
Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely used in Maternal.Dural Puncture Epidural Technique improves Labor Analgesia Quality And Safety By Increasing Drug Permeation.This study combines ultrasound real-time guidance technology. This technology ensures the accuracy of intervertebral space positioning and puncture success rate through operational visualization, and reduces the impact of operator proficiency on research results.
详细描述
Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely used in Maternal. The implementation step is to complete the epidural puncture, temporarily do not place a tube, puncture the dura mater with a subarachnoid anesthesia needle, but do not directly inject drugs into the subarachnoid space, and then leave an epidural catheter for administration according to epidural block. The theoretical basis is that anesthetic drugs can originally penetrate into the subarachnoid space from the epidural space through a complete spinal dura, and the puncture hole formed by spinal dura puncture facilitates this process.After injecting high volume anesthetic drugs into the epidural space, the pressure increases, and the drug penetrates from the epidural space through the puncture hole along a pressure gradient to the subarachnoid space, thereby enhancing the effect of labor analgesia.Dural Puncture Epidural also has the advantage of verifying that the epidural needle is in the middle of the epidural space again, thereby reducing the incidence of epidural catheter insertion failure or deviation to one side.This study combines ultrasound real-time guidance technology. This technology ensures the accuracy of intervertebral space positioning and puncture success rate through operational visualization, and reduces the impact of operator proficiency on research results.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) Class I or II;
- •Single healthy pregnancy;
- •Head showing first;
- •37 to 41 weeks;
- •The labor process is active, and the cervix dilates<5cm;
- •Require epidural labor analgesia;
- •Volunteer to participate in this study and sign an informed consent form.
排除标准
- •Presence of pregnancy diseases, such as pregnancy hypertension, pre eclampsia, pregnancy diabetes;
- •Contraindications to intraspinal analgesia: 1) Central nervous system diseases. 2) Infection or septicemia at the puncture site. 3) Coagulation dysfunction;
- •Known cases of fetal malformation or increased risk of cesarean section, such as a history of uterine rupture;
- •Persons with a history of mental illness, hysteria, epilepsy, etc. who cannot cooperate.
- •Patients with long-term use of opioids, steroids, and chronic pain.
结局指标
主要结局
The incidence of NICHD category elevation from baseline
时间窗: From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).
NICHD (National Institute of Child Health and Human Development) Fetal Heart Tracing Classification: Category I (normal), Category II (indeterminate), Category III (abnormal). A higher category (e.g., III vs. I) indicates a less reassuring fetal status.
次要结局
- Distribution of NICHD categories (I, II, III)(From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).)
- Fetal heart rate(From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).)
- Duration of individual uterine contractions(From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).)
- Incidence of hypertonus(From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).)
- Incidence of tachysystole(From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).)
- Uterine contraction frequency(From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).)
- Incidence of asymmetric block(During the labor analgesia period (assessed up to 24 hours))
- Sensory blockade level(During the labor analgesia period (assessed up to 24 hours))
- Time to analgesia onset(Within 30 minutes after initial drug administration)
- Number of patient-controlled analgesia (PCA) demands(Through the completion of labor analgesia (assessed from initiation to delivery, up to 24 hours).)
- Motor blockade assessed by the Modified Bromage Score(During the labor analgesia period (assessed up to 24 hours))
- Sensory blockade at the second sacral dermatome (S2)(During the labor analgesia period (assessed up to 24 hours))
- Visual Analogue Scale(Through the completion of labor analgesia (assessed from initiation to delivery, up to 24 hours).)
- Procedure-related complications of labor analgesia(From the time of the analgesia procedure until the completion of the study-specific follow-up period(assessed up to 1 week))
- Cesarean delivery rate(At delivery)
- Neonatal Apgar scores(At 1, 5, and 10 minutes after birth)
- Fetal heart rate variability(Baseline period (prior to analgesia initiation) and the analgesia period (from initiation to fetal delivery)(assessed up to 24 hours).)
- Fetal Heart Rate decelerations(Baseline period (prior to analgesia initiation) and the analgesia period (from initiation to fetal delivery)(assessed up to 24 hours).)
- Clinician interventions(The analgesia period (from initiation to fetal delivery)(assessed up to 24 hours).)
- Local anesthetic consumption(The analgesia period (from initiation to fetal delivery)(assessed up to 24 hours).)
- The duration of each stage of labor(From labor onset to delivery of placenta(assessed up to 24 hours).)
- Maternal body temperature(Pre-analgesia and at delivery)
- Side effects and complications of labor analgesia(From analgesia initiation until 72 hours after delivery (assessed up to 72 hours))
- Indications for cesarean delivery(At the time of cesarean delivery)
- Anesthetic technique for cesarean delivery(At the time of cesarean delivery)
研究者
Zongxun Lin
Principal Investigator
Fujian Provincial Hospital