Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia: a Randomised Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Time to Regression of Motor Block
研究概览
简要总结
Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite effective surgical anesthesia, bupivacaine is associated with long duration motor block and dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and faster regression of motor block compared to other local anesthetics without noteworthy side-effects when used intrathecally. The aim of this randomized, multicenter, powered clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric bupivacaine for scheduled caesarean delivery under spinal anesthesia, with more rapid rehabilitation and less adverse effects. Our hypothesis is that hyperbaric prilocaine offers shorter motor block and more rapid rehabilitation than bupivacaine.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Twin pregnancy
- •History of 2 cesarean section or more
- •Diabetes and gestational diabetes
- •Placenta praevia
- •Congenital foetal abnormality
- •Intrauterine growth retardation
- •Patient in labour
- •Membrane rupture
- •Known allergy to local anaesthetics
- •Standard contraindications to neuraxial block.
- •Disagreement of the patient
- •Neurological impairment
- •Gestational low blood pressure
- •Pre eclampsia and eclampsia
研究组 & 干预措施
Hyperbaric bupivacaine
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
干预措施: Hyperbaric bupivacaine (Drug)
Hyperbaric prilocaine
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
干预措施: Hyperbaric prilocaine (Drug)
结局指标
主要结局
Time to Regression of Motor Block
时间窗: until complete regression of motor block (up to 4 hours)
Time to regression of motor block is the time between maximal blockade (score 1, as evaluated by the Modified Bromage scale), and no blockade (score 6). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia, then every 15 minutes until the end of surgery, and thereafter, every 30 minutes until complete regression of motor block
次要结局
- Pain as Assessed by Visual Analogue Scale(up to 24 hours after surgery)
- Time to Motor Block Onset(From spinal injection of the local anesthetic to bilateral T4 level and during surgery (average 1 hour))
- Time to First Walk(up to 24h after surgery)
- Time From Baby Delivery to End of Surgery(average 1 hour)
- Time to Successful Anesthesia (Successful Sensory Block)(From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes))
- Time to Resolution of Sensory Block(until complete release of sensory block (T12-S1) (average 4 hours))
- Time of Surgery(average 1 hour)
- Obstetrician Satisfaction(average 1 hour)
- Midwife Satisfaction(72 hours after surgery)
- Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia(until complete release of sensory block (T12-S1) (average 4 hours))
- Number of Patients With Hypotension and Use of Vasopressors(up to 2 hours after surgery)
- Number of Participants With Urinary Retention(up to 4 hours after surgery)
- Newborn Methemoglobinemia (MetHb)(average 1 hour)
- Maternal Satisfaction Assessed by Visual Analogic Scale (VASS)(up to 24 hours after surgery)
- Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR)(up to 72 hours after surgery)
- Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)(up to 72 hours after surgery)
- Number of Participants With Transient Neurologic Symptoms (TNS)(up to 15 Days after surgery)
- Time From Spinal Injection to Baby Delivery(average 1 hour)
- Newborn Apgar Score(up to 10 minutes after baby extraction)
- Newborn Umbilical pH(average 1 hour)
- Total Blood Loss(average 1 hour)