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临床试验/NCT03231436
NCT03231436已完成不适用

Fixed Dose Versus Height - Adjusted Dose of Intrathecal Hyperbaric Bupivacaine With Opioid for Cesarean Delivery: a Prospective Double-blinded Randomized Trial

Bartosz Horosz, MD1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2017年7月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
Adequacy of spinal anesthesia

研究概览

简要总结

The study is designed to compare the effectiveness of spinal anesthesia performed with fixed dose of hyperbaric bupivacaine regardless of patient's height and weight and anesthesia with the dose of bupivacaine that is adjusted to their height. Our clinical experience shows that spinal anesthesia using specific, relatively high dose of hyperbaric bupivacaine combined with opioid is very effective, regardless of parturient's weight and height, provides very good surgical conditions and assures patient's comfort while the rate of anesthesia - related complications is similar or less. Therefore, using height-adjusted protocols, although preferred in some centres, might not be necessary in order to provide good anaesthesia for cesarean delivery. Fixed dose regimen may have some additional advantages in obstetric anesthesia settings, as many of cesareans are performed out of hours, giving less room for mistakes in less experienced hands.

Two groups of parturients undergoing cesarean section are to be compared: anesthetized with fixed-dose regimen (intervention group) and anesthetized with height-adjusted dose regimen (control group). Patients are going to be randomized to one of the above groups, two anesthetists will be involved in anesthetic procedure: anesthetist that looks after the patient throughout the procedure will be blinded to the dose of anesthetic given intrathecally. Therefore his judgment of anesthetic effectiveness is not going to be biased and all patients will receive the same perioperative care in terms of fluid therapy, management of possible anesthesia - related complications and postoperative pain control.

Rate of effective spinal anesthetics, defined as adequate block level and no need for additional intraoperative analgesia has been established as primary outcome measure. Secondary outcome measures are rate of complications and amount of opioids used postoperatively. These are going to be statistically compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • singleton pregnancy above 37Hbd scheduled for elective cesarean section
  • ASA 1 or 2

排除标准

  • absolute contraindications to spinal anesthesia
  • delivery in progress
  • non-singleton pregnancy
  • ultrasound - based estimation of fetal weight below 10 percentile
  • pregnancy-induced hypertension
  • more than 2 cesarean sections in patient's medical history
  • significantly increased risk of obstetric hemorrhage (placenta previa)

研究组 & 干预措施

Fixed dose of 12.5mg bupivacaine

Experimental

Participants that receive the same dose of intrathecal bupivacaine and 25mcg of fentanyl, regardless of their height.

干预措施: Fixed dose of 12.5mg bupivacaine (Drug)

Height-adjusted dose of bupivacaine

Active Comparator

Participants that receive the dose of intrathecal bupivacaine adjusted to their height and 25mcg of fentanyl

干预措施: Height-adjusted dose of bupivacaine (Drug)

结局指标

主要结局

Adequacy of spinal anesthesia

时间窗: 60min

Level of surgical anesthesia at least T5 and no need for additional intraoperative analgesia

次要结局

  • Number of complications(60min)
  • Postoperative opioid consumption(24hours)

研究者

发起方
Bartosz Horosz, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bartosz Horosz, MD

Principal Investigator

Centre of Postgraduate Medical Education

研究点 (1)

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