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临床试验/NCT02564016
NCT02564016终止不适用

Efficacy of Labor Epidurals for Postpartum Tubal Ligation: Effect of Postpartum Epidural Saline Infusion on the Reactivation of Labor Epidurals for Postpartum Tubal Ligation Following Vaginal Delivery

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
36
试验地点
1
主要终点
Number of Participants With Successful Epidural Reactivation

研究概览

简要总结

The goal of this study is to evaluate the effect of continuous postpartum epidural saline infusion on the reactivation of labor epidurals for postpartum tubal ligation surgery following vaginal delivery.

详细描述

The aim of this research is to determine the effect of postpartum epidural saline infusion on the reactivation of labor epidural catheters which are used as the anesthetic technique for PPTL following vaginal delivery. It is proposed that continuous epidural saline infusion will decrease the incidence of catheter obstruction by preventing clot, fibrosis, or tissue plugging and therefore improve reactivation rates. To our knowledge, this is a novel method for attempting to improve epidural reactivation rate and if successful, it would challenge the current practice of only capping epidurals following delivery and later attempting reactivation prior to PPTL. This may, possibly, become a new technique used to improve the rate of epidural reactivation for PPTL.

If study results show improved labor epidural reactivation rates, benefits would include decreased patient morbidity and greater patient comfort and satisfaction by avoiding the risks of additional neuraxial procedures as well as general anesthesia. These risks include difficult or failed intubation, aspiration, hypotension, headache, postoperative nausea and vomiting, and sore throat. Improving epidural reactivation rate could also result in greater OR efficiency and decreased costs for the patient and hospital.

The investigators also hope to elucidate factors associated with catheter migration or dislodgement and subsequent failure of epidural reactivation. Additionally, we hope to determine what effect obesity and length of time prior epidural reactivation have on epidural reactivation rates.

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
None

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

  • Pregnant women
  • 18 to 45 years of age
  • Admitted to MUSC in labor or for induction of labor resulting in a vaginal delivery epidural analgesia
  • Postpartum tubal ligation following delivery
  • American Society of Anesthesiologists (ASA) Physical Class 1, 2, and 3

排除标准

  • Critically Ill Patients (patients admitted to the ICU)
  • Cognitively Impaired Persons (patients with a diagnosis of cognitive deficit)
  • Cesarean delivery
  • Punctured dura
  • Patients enrolled in other epidural research studies

研究组 & 干预措施

Capped Epidural

Active Comparator

Group 1 (control) will have the epidural catheter capped and left in place.

干预措施: Capped Epidural (Other)

Normal Saline Infusion

Experimental

Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour

干预措施: Normal Saline Infusion (Drug)

结局指标

主要结局

Number of Participants With Successful Epidural Reactivation

时间窗: one year

The goal of this study is to evaluate the effect of continuous postpartum epidural saline infusion on the reactivation of labor epidurals for postpartum tubal ligation surgery following vaginal delivery.

次要结局

  • Count of Participants Who Experienced Epidural Reactivation Failure(one year)
  • Count of Participants Whose BMI Affected the Reactivation Rate of Labor Epidurals for Postpartum Tubal Ligation Surgery Following Vaginal Delivery.(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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