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临床试验/NCT04696627
NCT04696627已完成不适用

Long-term Complications of Unintentional Dural Puncture During Labour Epidurals and Epidural Blood Patch.

Samuel Lunenfeld Research Institute, Mount Sinai Hospital1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2021年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
126
试验地点
1
主要终点
Presence of Chronic headache - questionnaire

研究概览

简要总结

The investigators plan to evaluate long-term consequences of unintentional dural puncture in women who had this complication during labor epidural insertion at Mount Sinai Hospital. A dural puncture is the perforation of the dura mater (one of the layers protecting the brain and the spinal cord) by the needle that is used to find and place a catheter in the epidural space. A puncture will cause a leakage of cerebrospinal fluid through the dura that results in an acute and usually self-limited headache in half of patients who have this complication. The usual treatment for this complication is conservative with the use of oral medications like acetaminophen, anti-inflammatory and narcotics. In the severely symptomatic patient, the injection of blood in the epidural space is a more invasive approach performed to "patch" the hole that was created in the dura (epidural blood patch). The objective is to determine whether or not there is a risk of developing long-term effects from the unintentional dural puncture and its treatment by epidural blood patch by comparing women who had a dural puncture during their labour epidural insertion with or without an epidural blood patch with women who received an epidural but did not have a dural puncture during the same period of time.

The hypothesis is that women who had unintentional dural punctures during epidural insertion will develop long-term effects such as chronic headache, chronic backache, chronic auditory or visual disturbances and chronic disability more frequently than women who received an epidural but did not sustain a dural puncture. The investigators also hypothesize that the use of epidural blood patch may change the course of these complications.

详细描述

The investigators will study women who have sustained an unintentional dural puncture at least one year prior to the start date of the study, and the investigators will study cases occurring during a period of 5 years. These women will be matched by type of procedure (labor epidural), month of delivery and age with women who have received an epidural but did not sustain an unintentional dural puncture. The group of women who sustained dural punctures will be further divided into two groups, whether they have received epidural blood patch or not, to study the influence of the epidural blood patch on the outcomes. Women will have their anesthetic records reviewed to collect data on the anesthetic technique, presence of a dural puncture and treatment if applicable. All patients who qualify will be contacted and invited to take part in this study. Those consenting to the study will be interviewed by phone or answer the survey electronically. During the interview, they will answer questions derived from validated questionnaires for the majority of our outcomes of interest. In the few outcomes where a validated questionnaire does not exist, the investigators will search for our endpoint with dichotomic (yes/no) questions. The investigators will then compare the data gathered in the three different groups to validate or invalidate our hypothesis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All patients with well-documented recognized unintentional dural punctures during their labor epidural insertion at Mount Sinai Hospital from January 2015 to December 2019 will be approached for enrollment. Control patients who received labor epidural matched by month of delivery and age will also be approached for enrollment.

排除标准

  • Patients with preexisting symptoms of chronic headache, or any of the secondary outcomes prior to the unintentional dural puncture will be excluded from this study.

结局指标

主要结局

Presence of Chronic headache - questionnaire

时间窗: 3 months

The presence of chronic headache defined as pain that lasts or recurs for more than three months.

次要结局

  • Presence of Chronic lower back pain - questionnaire(3 months)
  • Presence of Chronic auditory impairment - questionnaire(3 months)
  • Presence of Chronic visual impairment - questionnaire(3 months)
  • Medical interventions for pain/impairment - questionnaire(3 months)
  • Pain disability index - questionnaire(3 months)

研究者

发起方
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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