The Effects of Sufentanil or Morphine Added to Hyperbaric Bupivacaine in Spinal Anaesthesia for Elective Caesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To evaluate the time it takes the patients administer a first analgesic bolus of morphine intravenous personally after subarachnoid anesthesia in elective cesarean section.
研究概览
简要总结
Two approved treatments for spinal anesthesia will be compared in women undergoing cesarean section.
It is usual to perform cesarean sections using spinal anesthesia with a local anesthetic (bupivacaine) plus some opioid, such as sufentanil or morphine. Both have been shown to decrease postoperative pain, but we try to check if one brings more benefit than the other.
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
- None
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
- •Patients of at least 18 years.
- •Patients at least 36 weeks gestation.
- •Patients scheduled for non-urgent cesarean section.
- •Patients classified in the physical state of the American Society of Anesthesiologists (ASA) as grade I-II, and without important fetal pathological conditions.
- •Signature of informed consent that allows them to be part of the study.
排除标准
- •Pregnant women who reject the spinal technique.
- •Patients with contraindication to spinal anesthesia.
- •Patients with ASA> II classification.
- •Patients with multiple pregnancy.
- •Patients with three or more previous cesareans,
- •Patients with BMI greater than or equal to 40 kg / m
- •Language barrier.
- •Patients with pre-eclampsia.
- •Patients with a history of chronic pain.
- •Patients with a history of psychiatric or drug abuse.
- •Patients with allergy to any of the drugs used in the study.
研究组 & 干预措施
Hyperbaric bupivacaine+Sufentanil
To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: sufentanil (5 mcg)
干预措施: Hyperbaric bupivacaine+Sufentanil (Drug)
Hyperbaric bupivacaine+morphine
To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: morphine (0,01 mg)
干预措施: Hyperbaric bupivacaine+Morphine (Drug)
结局指标
主要结局
To evaluate the time it takes the patients administer a first analgesic bolus of morphine intravenous personally after subarachnoid anesthesia in elective cesarean section.
时间窗: 3 days
To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine plus opioid: sufentanil or morphine, produces a longer time for the patient to administer a first analgesic bolus of intravenous morphine.
次要结局
- Lower intravenous morphine consumption(24 hours after surgery)
- Mother´s side effects with respect to hemodynamic alteration, nausea, vomits, pruritus, tremor, urinary retention, sedation, respiratory depression, headaches, motor deficits, permanent sensory or autonomic deficits.(At intraoperative)
- Beginning of sitting and standing(At 48 hours after surgery)
- Levels of minor pain verbal scales(At 3, 6, 12 and 24 hours after surgery)