Comparison of Sensory Block Onset Time Between Epidural and Dural Puncture Epidural (DPE) Anesthesia for Cesarean Delivery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Time (minutes) to achieve bilateral T6 sensory block
研究概览
简要总结
The goal of this clinical trial is to compare the onset of sensory block between epidural anesthesia and dural puncture epidural (DPE) in patients undergoing elective cesarean delivery. The study also aims to evaluate hemodynamic stability and procedure-related side effects associated with both techniques.
The main questions it aims to answer are:
- What is the difference in the onset of sensory block between epidural anesthesia and dural puncture epidural (DPE) in patients undergoing cesarean section?
- Are there differences in hemodynamic stability between epidural anesthesia and DPE during surgery?
- What procedure-related side effects occur with each anesthetic technique?
Researchers will compare epidural anesthesia with dural puncture epidural (DPE) to determine which technique achieves a faster and more effective sensory block while maintaining maternal hemodynamic stability.
Participants will:
- Be randomly assigned to receive either epidural anesthesia or DPE anesthesia
- Undergo elective cesarean delivery under regional anesthesia
- Have sensory block onset, hemodynamic parameters, and adverse events monitored and recorded intraoperatively
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women scheduled to undergo cesarean delivery
- •American Society of Anesthesiologists (ASA) physical status II-III
- •Willing to participate in the study by providing written informed consent
排除标准
- •Patients with absolute contraindications to neuraxial anesthesia
- •Patients with known allergy or history of allergy to medications used in the study
- •Patients with psychiatric disorders or who are uncooperative
- •Patients with accidental dural puncture
- •Dropout Criteria:
- •Patients who require conversion to general anesthesia during the procedure
- •Patients who experience major intraoperative complications (massive hemorrhage, shock, or cardiac arrest)
结局指标
主要结局
Time (minutes) to achieve bilateral T6 sensory block
时间窗: From an anesthetic injection to the achievement of sensory and motor block during surgery (intraoperative period).
Sensory block onset is defined as the time from anesthetic injection until the achievement of sensory block at the T6 dermatome on both the left and right sides. The measurement is recorded in minutes using a stopwatch.
Time (minutes) to achieve Bromage grade 3 motor block
时间窗: From an anesthetic injection to the achievement of sensory and motor block during surgery (intraoperative period)
Motor block onset is defined as the time from anesthetic injection until the achievement of Bromage grade 3 motor block (inability to raise the straight leg). The measurement is recorded in minutes using a stopwatch.
次要结局
- Mean Arterial Pressure (MAP)(From baseline (minute 0) to 20 minutes after anesthetic administration during surgery)
- Heart Rate (HR)(From baseline (minute 0) to 20 minutes after anesthetic administration during surgery)
- Number of participants with Post-dural Puncture Headache (PDPH)(Within 72 hours after neuraxial anesthesia)
- Number of participants with nausea and/or vomiting(During anesthetic administration and surgery)
- APGAR Score(At 1 and 5 minutes after birth)
- Number of participants with hypotension(From anesthetic administration until the end of surgery)
研究者
Naufal Anasy
Principal Investigator
Gadjah Mada University