A Comparative Study Between Hyperbaric Prilocaine 2% Versus Hyperbaric Bupivacaine 0.5% For Intrathecal Anesthesia in Caesarean Section
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Measurment of onset time and duration of sensory block of Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% using pinprick sensation test in women undergoing caesarean section
研究概览
简要总结
Comparison between effects of hyperbaric bupivacaine 0.5% vs Hyperbaric prilocaine 2% in spinal anesthesia of women undergoing elective caesarean section such as onset time of sensory and motor block, duration of sensory and motor block, effects of maternal hemodynamics and expected side effects .
详细描述
Patients will be randomly allocated into two groups:
- Prilocaine Group (Group A):
- Patients will receive 60 mg of hyperbaric prilocaine 2% intrathecally.
- The anesthetic solution will be injected intrathecally using a 25 Gauge spinal needle, with the patient in a sitting position (midline or paramedian technique).
- The injection will be performed at the L3-L4 or L4-L5 interspace.
- Bupivacaine Group (Group B):
- Patients will receive 12.5 mg of hyperbaric bupivacaine 0.5% intrathecally.
- The anesthetic solution will be injected intrathecally using a 25 Gauge spinal needle, with the patient in a sitting position (midline or paramedian technique) .
- The injection will be performed at the L3-L4 or L4-L5 interspace.
Procedure Details:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18-45 years.
- •Patients with uncomplicated pregnancies.
- •American society of anesthesiologist (ASA) physical status I or II.
- •Height between 155 cm and 175 cm.
- •Written informed consent provided. -
排除标准
- •Patients with known allergies to local anesthetics.
- •Contraindications to intrathecal anesthesia (e.g., infection at the injection site and coagulopathy).
- •Severe preeclampsia or eclampsia.
- •Presence of significant comorbidities (e.g., uncontrolled diabetes, hypertension, renal or hepatic dysfunction).
- •History of spinal surgery or significant spinal deformity.
- •Patients who refuse to participate in the study -
研究组 & 干预措施
patients of group A will receive 60mg of hyperbaric prilocaine 2% for spinal anesthesia
干预措施: spinal anesthesia (hyperbaric Prilocaine 2%) (Drug)
patients of group B will receive 12.5mg heavy bupivacaine for spinal anesthesia
干预措施: Spinal anesthesia (heavy bupivacaine 0.5%) (Drug)
结局指标
主要结局
Measurment of onset time and duration of sensory block of Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% using pinprick sensation test in women undergoing caesarean section
时间窗: 12 HOURS
2- Measurment of onset time and duration of motor block of Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% using modified bromage scale in women undergoing caesarean section
时间窗: 12 hours
次要结局
未报告次要终点
研究者
Mostafa Mohamed Abdelgaber
A Comparative Study between Hyperbaric Prilocaine 2% versus Hyperbaric Bupivacaine 0.5% For Intrathecal Anesthesia in Caesarean Section
Sohag University