Zhou Shuangqiong, Cao Xiuhong, Zhou Yao, Xu Zhendong
Department of Anesthesiology, Shanghai Key Laboratory of Maternal Fetal Medicine, Shanghai Institute of Maternal-Fetal Medicine and Gynecologic Oncology, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, Shanghai, People's Republic of China.
J Pain Res. 2025 May 16;18:2509-2519. doi: 10.2147/JPR.S514780. eCollection 2025.
The dural-puncture epidural (DPE) and standard epidural (EP) techniques are well-established methods for neuraxial analgesia during labor. However, there is limited knowledge regarding the conversion of DPE-induced labor analgesia to surgical anesthesia during cesarean sections, particularly regarding efficacy and timing. This study will compare the surgical anesthesia onset time between DPE and EP in parturients undergoing emergency cesarean delivery after conversion from labor analgesia.
This double-blind, randomized clinical study will include 124 parturients. Parturients aged ≥18 years with singleton pregnancies who request labor analgesia will be randomly assigned to receive either DPE or EP anesthesia in the labor and delivery rooms. Participants will be excluded if they have contraindications to neuraxial anesthesia, back surgery or scoliosis history, significant fetal anomalies, or a known allergy to any of the study medications. Epidural labor analgesia will be maintained using a low concentration of ropivacaine in combination with sufentanil, delivered through the epidural catheter. During delivery, an emergency intrapartum cesarean section following labor analgesia may be necessary among these parturients. Parturients requiring intrapartum cesarean delivery following labor analgesia will be eligible. Epidural extension anesthesia will be administered in the operating room. The primary outcome measure will be the time from chloroprocaine administration to the achievement of a surgical level of anesthesia, defined as a T6 sensory block. Secondary outcomes will include epidural anesthesia quality, incidence of conversion to cesarean section between the two techniques, and maternal and neonatal outcomes.
This study will estimate the onset time to achieve surgical anesthesia during epidural extension using a DPE compared to an EP technique. The results may provide a deeper understanding of the advantages of the DPE technique in labor analgesia, as well as determine the onset time and reliability of anesthesia block during conversion from labor analgesia to cesarean delivery.
ChiCTR2400089237. Registered September 4, 2024.
硬膜穿刺硬膜外(DPE)和标准硬膜外(EP)技术是分娩期间实施椎管内镇痛的成熟方法。然而,关于剖宫产时将DPE诱导的分娩镇痛转换为手术麻醉的相关知识有限,尤其是在疗效和时机方面。本研究将比较分娩镇痛转换后行急诊剖宫产的产妇中,DPE和EP的手术麻醉起效时间。
这项双盲、随机临床研究将纳入124名产妇。年龄≥18岁、单胎妊娠且要求分娩镇痛的产妇将被随机分配至产房接受DPE或EP麻醉。若有椎管内麻醉禁忌证、背部手术或脊柱侧弯病史、严重胎儿畸形或已知对任何研究药物过敏,则排除参与者。硬膜外分娩镇痛将使用低浓度罗哌卡因联合舒芬太尼,通过硬膜外导管给药维持。分娩期间,这些产妇中可能有必要在分娩镇痛后行急诊剖宫产。分娩镇痛后需要行剖宫产的产妇符合条件。在手术室给予硬膜外延长麻醉。主要结局指标将是从给予氯普鲁卡因到达到手术麻醉平面(定义为T6感觉阻滞)的时间。次要结局将包括硬膜外麻醉质量、两种技术之间剖宫产转换率以及母婴结局。
本研究将评估与EP技术相比,使用DPE进行硬膜外延长时达到手术麻醉的起效时间。结果可能会更深入地了解DPE技术在分娩镇痛中的优势,以及确定从分娩镇痛转换为剖宫产时麻醉阻滞的起效时间和可靠性。
ChiCTR2400089237。2024年9月4日注册。