Comparison of Dural Puncture Epidural and Standard Epidural Anesthesia Techniques in Elective Cesarean Deliveries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- onset time of sensory block
研究概览
简要总结
Neuraxial techniques are the most effective form of labor analgesia in contemporary obstetric anesthesia practice, predominantly through the use of epidural (EPL) and combined spinal-epidural (CSE) techniques. Although drug combinations employed in these methods have advanced, the onset time, block quality, and side effect profiles of both techniques still require further improvement.
The epidural technique is associated with minimal side effects; however, it may occasionally present variable block characteristics such as slow onset, inadequate sacral spread, unilateral or patchy sensory block, motor impairment, and epidural catheter failure.
The dural puncture epidural (DPE) technique is performed by inserting a spinal needle through the shaft of the epidural needle to create a single dural perforation, after which an epidural catheter is placed into the epidural space without administering any drugs into the cerebrospinal fluid (CSF). All medications for analgesia or anesthesia are delivered into the epidural space via the catheter. The dural puncture is thought to provide a conduit that facilitates the translocation of drugs from the epidural space into the subarachnoid space, which is believed to account for the clinical features observed with the dural puncture epidural technique advantageous in obstetric patients. Additionally, the process of dural puncture with a spinal needle through the epidural needle allows cerebrospinal fluid return to serve as a "confirmatory" definitive endpoint for the position of the epidural needle tip within the epidural space.
The investigators designed this study to determine whether the dural puncture epidural technique, compared with epidural, could improve the onset time and block characteristics of anesthesia in elective cesarean deliveries.
Compared with the epidural technique, the dural puncture epidural approach has been shown to improve the onset of sacral block as well as the spread of anesthesia and analgesia-characteristics that are particularly advantageous in obstetric patients. Additionally, the process of dural puncture with a spinal needle through the epidural needle allows cerebrospinal fluid return to serve as a "confirmatory" definitive endpoint for the position of the epidural needle tip within the epidural space.
The investigators designed this study to determine whether the dural puncture epidural technique, compared with epidural, could improve the onset time and block characteristics of anesthesia in elective cesarean deliveries.
详细描述
This study aims to evaluate the effects of dural puncture epidural (DPE) versus standard epidural anesthesia on the time to surgical anesthesia onset in patients scheduled for elective cesarean section.
• Study Population:
Pregnant women undergoing elective cesarean section
• Compared Techniques:
Dural Puncture Epidural Group → A dural puncture will be performed with a 27G spinal needle before the placement of the epidural catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women scheduled for elective cesarean delivery
- •No comorbidities
- •Age between 18-40 years
- •Body mass index (BMI) < 35 kg/m²
- •Term pregnancy ≥ 37 weeks
- •No contraindications to neuraxial anesthesia (e.g., coagulopathy, infection, history of prior spinal surgery, etc.)
排除标准
- •Contraindications to neuraxial anesthesia
- •Refusal to participate in the study
研究组 & 干预措施
dural puncture epidural
The epidural space will be accessed using an 18G epidural needle, followed by dural puncture with a 27G spinal needle. Without administering any drug into the cerebrospinal fluid (CSF), an epidural catheter will then be inserted, through which anesthesia will be administered.Its placement will be confirmed with a test dose of 2 ml of 2% lidocaine. Following the test dose (after excluding signs of intrathecal or intravenous injection), a mixture consisting of 7.5 ml of 2% prilocaine, 7.5 ml of 0.5% bupivacaine, and 100 µg of fentanyl (2 ml) will be administered in 5-ml increments at 3-minute intervals. At the completion of the injection (t0), the patient will be placed in the supine position with a 10-degree left tilt. Sensory block level will be assessed every minute using the pinprick test. Bilateral sensory block at the T5 dermatome will be accepted as adequate surgical anaesthesia.
干预措施: Dural puncture epidural (DPE) anaesthesia (Other)
standart epidural anesthesia
The epidural space will be accessed using an 18G epidural needle. An epidural catheter will then be inserted, through which anesthesia will be administered.Its placement will be confirmed with a test dose of 2 ml of 2% lidocaine. Following the test dose (after excluding signs of intrathecal or intravenous injection), a mixture consisting of 7.5 ml of 2% prilocaine, 7.5 ml of 0.5% bupivacaine, and 100 µg of fentanyl (2 ml) will be administered in 5-ml increments at 3-minute intervals. At the completion of the injection (t0), the patient will be placed in the supine position with a 10-degree left tilt. Sensory block level will be assessed every minute using the pinprick test. Bilateral sensory block at the T5 dermatome will be accepted as adequate surgical anaesthesia.
干预措施: standart epidural anesthesia (Other)
结局指标
主要结局
onset time of sensory block
时间窗: 20 minutes
The time from the administration of anesthesia to the onset of surgical anesthesia (the time it takes for the sensory block to reach the Thoracic 5 (T5) dermatome).
次要结局
- Incidence of hypotension(perioperative)
- intraoperative ephedrine requirement(perioperative)
- requirement for supplementery dosing(perioperative)
- Postdural puncture headache (PDPH)(day 2)
- Time to the onset of sensory block regression(day 1)
- Assessment of motor block(day 1)
研究者
Esra Uyar Türkyılmaz
associate professor,MD
Ankara City Hospital Bilkent