跳至主要内容
临床试验/NCT02369510
NCT02369510已完成4 期

Does the Addition of Epinephrine Increase the Duration of Intrathecal Hyperbaric Bupivacaine for Repeat Cesarean Section?

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
68
试验地点
1
主要终点
Sensory Recovery

研究概览

简要总结

The purpose of this study is to investigate whether the addition of a medication called epinephrine to spinal medications prolongs the duration of the anesthesia. The medication standardly used in spinal anesthesia is a local anesthetic (bupivacaine) and an opiate pain medication (morphine). These medications typically last about 2 hours. The investigators want to determine if adding epinephrine to the spinal medications prolongs the anesthetic without side effects. A longer duration of anesthesia may be useful in prolonged repeat cesarean section. Epinephrine is known to prolong the action of some local anesthetics, but the investigators want to specifically study combining it with the medications the investigators use regularly for cesarean section.

You may qualify to take part in this research study because you are having a repeat cesarean section. Repeat cesarean sections sometimes last longer than 2 hours. The investigators want to determine if epinephrine will prolong the anesthetic.

详细描述

Spinal anesthesia with bupivacaine is a commonly used anesthetic in the obstetric population. It is most frequently carried out as a single shot intrathecal injection. This method can be utilized for both labor analgesia and surgical anesthesia for cesarean section. One of the concerns in using a single shot spinal injection for surgical anesthesia is the duration of adequate surgical conditions. This concern is especially relevant to repeat cesarean sections, as each subsequent procedure has the potential to be more complex than the prior and, therefore, prolonged. A reliable way to prolong surgical anesthesia provided by single shot spinal injection of bupivacaine could prove invaluable in the setting of repeat cesarean section. It has been well documented that adding epinephrine to intrathecal lidocaine will increase its duration1, but the evidence for augmenting the duration of anesthesia provided by adding epinephrine to bupivacaine is much more equivocal and less robust. This is a randomized control trial investigating whether or not adding epinephrine to a standard single intrathecal injection of hyperbaric bupivacaine for repeat cesarean will prolong its duration. It will be investigated using women who are undergoing scheduled repeat cesarean section in whom neuraxial anesthesia is the appropriate primary anesthetic. The investigators will compare the onset, quality and duration of both sensory and motor components of the spinal block as well as the incidence of known side effects.

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, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Non-emergent repeat cesarean section
  • Neuraxial anesthesia as the planned primary anesthetic
  • Informed consent obtained
  • Females age 18-50

排除标准

  • Emergency cesarean section
  • Anesthetic other than neuraxial
  • Allergy to local anesthetics, morphine, or epinephrine
  • Pre-existing sensory/motor deficit

研究组 & 干预措施

Low-dose epinephrine

Experimental

100micrograms of epinephrine group

干预措施: Low-dose epinephrine (Drug)

High-dose epinephrine

Experimental

200micrograms of epinephrine group

干预措施: High-dose epinephrine (Drug)

No epinephrine

Placebo Comparator

0.2ml saline

干预措施: No epinephrine (Drug)

结局指标

主要结局

Sensory Recovery

时间窗: up to 3 hours

Time to T10 sensory recovery as measured by pinprick sensation

次要结局

  • Motor Recovery(up to 4 hours)
  • Adequacy of Anesthesia(up to 3 hrs)
  • Patient Satisfaction(up to 3 hours)
  • Incidence of Nausea and Vomiting(up to 3 hours)
  • Incidence of Pruritus(up to 3 hours)
  • Block Onset(up to 15 min)
  • Number of Participants With Hypotension(at 2 minutes and at 25 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Katz

Assistant Professor of Anesthesiology

Icahn School of Medicine at Mount Sinai

研究点 (1)

Loading locations...

相似试验