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临床试验/NCT01682967
NCT01682967已完成不适用

Alteration in Hearing Following Accidental Dural Puncture. A Study in Parturients

Örebro University, Sweden2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
Post-dural puncture headache

研究概览

简要总结

Headache following accidental dural punction as during epidural analgesia can be severe and sometimes very disabling. The incidence of PDPH is 10-40%, most starting within 48 h of dural puncture. Although spontaneous resolution of headaches is common in most patients within 7 days, in 20% can they be persistent and in some very disabling. The exact reason for the characteristic headache is unknown, but it is believed to be the result of leakage of cerebro-spinal fluid (CSF) from the dural puncture. The greater the leakage of CSF, the more severe and persistent the headache. This is why larger needles (lower gauge) are known to have a higher incidence of PDPH. However, the type of needle also seems to play an important role in the likelihood of PDPH.

Headache following accidental PDPH is very typical as it increases significantly when sitting or standing and often disappears completely on lying down. It is typically located in the back of the head, accentuated by light and often decreases with intake of large quantity of fluids. In many cases, it is self-limiting and most often decreases with time and bed rest.

Diagnosis of PDPH is clinical and sometimes difficult. It is well known that liquor leakage, as following spinal anaesthesia, results in partial loss of unilateral or bilateral hearing that can be detected by oto-acoustic hearing loss. We plan to use this knowledge and test the hypothesis that measurement of hearing loss may be a diagnostic method for confirmation of clinical symptoms and signs of accidental PDPH.

详细描述

Parturients who have received epidural analgesia during labour would be included in this study and these would comprise of:

  1. patients without clinical symptoms of postdural puncture headache
  2. patients with clinical symptoms of postdural puncture headache

In addition, a control group of parturients who have not received an epidural analgesia would constitute the control group.

All patients would have audiometry (oto-acoustic emission - OAE, and auditory steady state response - ASSR) done following diagnosis of PDPH. Subsequently, the patients would be observed for 24 h to assess whether the headache resolves spontaneously. A new audiometry would be done at this stage. Those patients with substantial evidence of PDPH at this stage would receive an epidural blood patch (EBP) and a new audiometric assessment would be made after 4 h and 24 h to assess whether any audiometric deficit has resolved or not. All patients would have a similar measurement of hearing after 3 months when it is believed that most patients have returned to normal hearing. In addition to audiometric analysis, patients would be asked to fill out a detailed PDPH questionnaire at the same time periods.

All measurements would be compared with patients who have received an EDA but without PDPH and those who have not received an EDA.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy parturients No known hearing problems Understand Swedish language Informed consent

排除标准

  • Taking steroid medication Having pre-eclampsia

结局指标

主要结局

Post-dural puncture headache

时间窗: 4 h after epidural blood patch

VAS pain (headache) 4 h after application of EBP

次要结局

  • Recurrence of Headache(24 h after application of EBP)
  • Audiometric data(4 h following EBP)
  • PDPH questionnaire(4 h after application of EBP)

研究者

发起方
Örebro University, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anil Gupta

Associate Professor

Örebro University, Sweden

研究点 (2)

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