A Prospective Randomized Double Blind Comparison of 7,5 mg Hyperbaric Bupivacaine With 2,5mcg Sufentanyl or 50 mg Hyperbaric Prilocaine With 2,5 mcg Sufentanyl for Caesarean Sections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 3
- 主要终点
- onset time surgical readiness
研究概览
简要总结
Prilocaine theoretically could provide faster onset because of its lower pKa (7,7) compared to bupivacaine (8,1). The primary objective of this prospective double blind randomized trial is to determine block onset of spinal hyperbaric prilocaine compared to bupivacaine, both with a small dose of sufentanyl as an additive.The primary hypothesis is that a significant larger amount of patients will gain surgical readiness within 8 minutes after spinal injection of prilocaine with sufentanyl compared to bupivacaine with sufentanyl. Surgical readiness is defined as a sensory block level of T5 tested by loss of cold sensation.
详细描述
This study is designed as a randomised prospective double blind multi centre study.
Following approval by the Hospital Ethics committee of the University Hospital Antwerp and all participating hospitals, all-in term (37-42 weeks of gestation) pregnant women planned for a caesarean section will be asked to participate in this trial.
Patients will be randomised to receive either spinal prilocaine with sufentanyl or spinal bupivacaine with sufentanyl.The patient, the anaesthetist performing the CSE and the observer are not aware of the local anaesthetic solution administered.
Preoperative a combined spinal epidural puncture will be performed in the sitting position at the level of L2-L3 or L3-L4 . Vital parameters will be registered at regular intervals. Block characteristics ( onset, duration and intensity of the sensory block and motor block) will be measured at regular intervals.
Patients with insufficient analgesia will receive a top up dose of 5 ml lidocaine 2 % via the epidural catheter.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The spinal solution will be prepared by an independent anaesthetist, anaesthetist trainee or research nurse on a sterile table after opening the sealed envelope with the appointed study group. The patient, the anaesthetist performing the CSE and the observer are not aware of the local anaesthetic solution administered.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A term Pregnant women (37-42 weeks)scheduled for caesarian section
排除标准
- •Patient refusal
- •Twin or multiple pregnancy
- •Preeclampsia
- •Contraindication neuraxial technique
- •Indication general anaesthesia
- •BMI before pregnancy >35
- •Maternal height <155 cm
研究组 & 干预措施
Group M
combined spinal epidural anesthesia with spinal administration of 7,5 mg hyperbaric bupivacaine 0,5% (Marcaine H) + 2,5mcg sufentanyl ( 5 mcg/ml)( Janssens -cilag) +1 ml nacl0,9%
干预措施: combined spinal epidural anaesthesia (Procedure)
Group M
combined spinal epidural anesthesia with spinal administration of 7,5 mg hyperbaric bupivacaine 0,5% (Marcaine H) + 2,5mcg sufentanyl ( 5 mcg/ml)( Janssens -cilag) +1 ml nacl0,9%
干预措施: Bupivacaine (Drug)
Group P
A combined spinal epidural anesthesia with spinal administration of 50 mg hyperbaric prilocaine 2% (Tachipri, Nordic Pharma) + 2,5mcg sufentanyl (5 mcg/ml) (Janssens-cilag)
干预措施: combined spinal epidural anaesthesia (Procedure)
Group P
A combined spinal epidural anesthesia with spinal administration of 50 mg hyperbaric prilocaine 2% (Tachipri, Nordic Pharma) + 2,5mcg sufentanyl (5 mcg/ml) (Janssens-cilag)
干预措施: Prilocaine (Drug)
结局指标
主要结局
onset time surgical readiness
时间窗: from start spinal anaesthesia to start of surgery (up to 30 minutes)
amount of minutes from spinal injection (T0) to loss of cold sensation on the fifth thoracic dermatome
次要结局
- sensory block level(Up to 3 hours)
- occurrence of hypotension(from spinal injection(T0) to motor block regression ( up to 3 hours))
- discharge time maternity ward(Up to 3 hours)
- regression interval of the motor block(up to 3 hours)
- First Breast feed(up to 6 hours)
研究者
Dr M. B. Breebaart
MD, PhD
University Hospital, Antwerp