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临床试验/NCT03760718
NCT03760718Unknown早期 1 期

Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年9月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
15
试验地点
1
主要终点
Chloroprocaine Plasma Concentration at 1 Minute

研究概览

简要总结

The long term objective is to show that intraperitoneal chloroprocaine can be used an alternative option to avoid general anesthesia during cesarean delivery, to alleviate mother's discomfort from surgical pain, reduce complications, and improve the birth experience. The objectives in this study are to determine the amount of chloroprocaine that is absorbed into the blood in order to create a plasma concentration time profile and to determine the incidence of side effects to help guide selection of an appropriate concentration for future study.

详细描述

Compared to general anesthesia, neuraxial anesthesia (spinals and epidurals) is associated with a lower risk for maternal aspiration and airway compromise, exposes the baby to less anesthetic, and allows for greater maternal involvement in the birth process. For these reasons, it has become the preferred method of anesthesia for cesarean delivery. Spinals that are placed to facilitate cesarean delivery have a duration of one to two hours. Currently, if that duration is exceeded patients must have general endotracheal anesthesia. In addition, suboptimal neuraxial anesthesia for cesarean delivery is not uncommon with an incidence of 2-9%, depending upon the urgency of surgery and the type of neuraxial block. Providing less than adequate anesthesia for cesarean delivery may increase the risk of legal liability. For this reason, some patients with suboptimal neuraxial anesthesia have intraoperative conversion to general endotracheal anesthesia.

The first known description of the use of intraperitoneal local anesthetic to provide anesthesia for cesarean delivery was published in 1975. In this article Ranney et al. described how to use up to 100 mL of 1% procaine to provide anesthesia for cesarean delivery under local field block alone. Some of this was injected into the skin and fascia, and the remainder was diluted to 0.5% and "spilled" into the peritoneum.

Multiple publications have shown that intraperitoneal local anesthetic can be used to treat intraoperative and postoperative pain, prevent postoperative nausea, and shorten hospital length of stay. A recently published 40-month case series showed that chloroprocaine lavage can be used as part of a multimodal approach to treating intraoperative pain. In this case series, the technique of chloroprocaine lavage helped investigators to avoid general endotracheal anesthesia in 32 women having a cesarean delivery.

In this case series, no patients exhibited clinical signs of systemic local anesthetic toxicity. It is believed that chloroprocaine has a limited potential for toxicity because of its short plasma half-life, which is only 11-21 seconds. The purpose of this study is to determine the amount of chloroprocaine that is taken up into the blood stream after intraperitoneal administration to ensure that blood levels are low and do not raise a safety concern. Data obtained from this study will help to define a safe dose of chloroprocaine for intraperitoneal administration.

研究设计

研究类型
Interventional
分配方式
Non 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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Subjects ≥ 18 to 50 years of age having scheduled cesarean sections on 12C (Labor and Delivery) within Oregon Health & Science University (OHSU).
  • Only subjects having spinal anesthesia will be eligible.
  • Only subjects that can have a Pfannenstiel incision will be enrolled.

排除标准

  • Subjects with chronic narcotic usage
  • Subjects that are deemed to need a combined spinal epidural for any reason.
  • Subjects who are unable to successfully get a spinal block
  • Subjects with known atypical cholinesterase activity
  • American Society of Anesthesiologist physical status IV or higher
  • Subjects with contraindication to neuraxial anesthesia (coagulopathy, infection)
  • Subjects with stage 4 chronic kidney disease or worse (eGFR < 30 ml/min)
  • Subjects with significant hepatic dysfunction (AST or ALT > 2x the upper limit of normal)
  • Subjects with allergies to drugs required for this protocol.
  • Subjects with multifetal gestations
  • Subjects with a BMI > 40 kg/m2

研究组 & 干预措施

Preservative free Chloroprocaine Group 1

Active Comparator

40 ml of preservative-free 1% chloroprocaine

干预措施: Preservative free 1% Chloroprocaine (Drug)

Preservative free Chloroprocaine Group 2

Active Comparator

40 ml of preservative-free 2% chloroprocaine

干预措施: Preservative free 2% Chloroprocaine (Drug)

Preservative free Chloroprocaine Group 3

Active Comparator

40 ml of preservative-free 3% chloroprocaine

干预措施: Preservative free 3% Chloroprocaine (Drug)

结局指标

主要结局

Chloroprocaine Plasma Concentration at 1 Minute

时间窗: 1 minute after intraperitoneal chloroprocaine administration

The chloroprocaine plasma concentration obtained from a venous sample 1 minute after intraperitoneal chloroprocaine administration.

Chloroprocaine Plasma Concentration at 5 Minutes

时间窗: 5 minutes after intraperitoneal chloroprocaine administration

The chloroprocaine plasma concentration obtained from a venous sample 5 minutes after intraperitoneal chloroprocaine administration.

Chloroprocaine Plasma Concentration at 10 Minutes

时间窗: 10 minutes after intraperitoneal chloroprocaine administration

The chloroprocaine plasma concentration obtained from a venous sample 10 minutes after intraperitoneal chloroprocaine administration.

Chloroprocaine Plasma Concentration at 20 Minutes

时间窗: 20 minutes after intraperitoneal chloroprocaine administration

The chloroprocaine plasma concentration obtained from a venous sample 20 minutes after intraperitoneal chloroprocaine administration.

Chloroprocaine Plasma Concentration at 30 Minutes

时间窗: 30 minutes after intraperitoneal chloroprocaine administration

The chloroprocaine plasma concentration obtained from a venous sample 30 minutes after intraperitoneal chloroprocaine administration.

次要结局

未报告次要终点

研究者

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

Brandon M Togioka

Principal Investigator

Oregon Health and Science University

研究点 (1)

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