A Randomized Comparative Study on the Effect of Using Intrathecal Hyperbaric Prilocaine Plus Fentanyl Compared to Hyperbaric Bupivacaine Plus Fentanyl on the Motor Block in Women Undergoing Caesarean Section Under Spinal Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- time to motor block
研究概览
简要总结
To compare the effects of using intrathecal prilocaine combined with fentanyl on duration of motor block versus that of intrathecal bupivacaine combined with fentanyl in elective caesarean section.
详细描述
The participants in this study will be randomized into two groups based on computer generated numbers using online randomization program (research randomizer). Upon arrival to the operating room, patients will be monitored using electrocardiography, pulse oximetry, and non-invasive blood pressure monitor. The baseline values will be recorded .Heart rate and peripheral oxygen saturation (SpO2) will be monitored continuously; systolic, diastolic, and mean arterial pressure (MAP) will be measured noninvasively at 5 minutes interval during the procedure and during the PACU stay. An 18G-cannulae will be inserted, and pre-medication drugs will be delivered (metoclopramide 10mg). and 4-8 mL/ kg crystalloid infusion will be initiated . Nasal oxygen 3 L / min will be administered during the whole procedure.
- Group P: patients assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml).
- Group B: patient assigned to this group will receive intrathecal 10 mg (2 ml) of bupivacaine 5% (sunnypivacaine hyperbaric bupivacaine 20 mg/4ml + 25 ug fentanyl (0.5 ml).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age (18-35)
- •Singleton, full term pregnant females.
- •Height (1.60-1.90) m.
- •BMI > 35 kg m-2
- •Scheduled for elective caesarean section under spinal anesthesia.
排除标准
- •Patients requiring general anaesthesia
- •Known or suspected coagulopathy (international normalised ratio > 1.4), thrombocytopenia (platelet count < 100,000).
- •Known peripheral neuropathy, neurological deficits or skeletal deformities.
- •Known allergy to prilocaine, bupivacaine , fentanyl.
- •Infection at site of injection.
- •Patients' refusal to sign informed consent
- •Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction less than 50%, heart block and arrhythmias), hypertensive disorders of pregnancy, peripartum bleeding.
研究组 & 干预措施
prilocaine
干预措施: prilocaine (Drug)
bupivacaine
干预措施: bupivacaine (Drug)
结局指标
主要结局
time to motor block
时间窗: time from intrathecal drug injection and time to unassisted ambulation or Bromage's score = 0 (no motor block) (from3 to 5 minutes).
次要结局
- time to sensory block (T4)(time from intrathecal drug injection and complete absence of skin sensation to the pinprick test at T4 (from 1 to 5 minutes))
研究者
Yasmin Hassab elnaby
associate professor
Cairo University