Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Hearing loss
研究概览
简要总结
The study involves assessment of hearing and visual complications along with headache after accidental dural puncture in patients receiving epidurals. Hearing loss will be assessed by clinical examination and audiometry testing, while visual complications will be assessed by clinical examination. The patients will receive standard treatment for headache in the form of drugs and if required an epidural blood patch ( injecting patient's blood in the epidural space). The course of these complications and response to treatment will be investigated over a period of time.
Audiometry results from patients with dural puncture will be compared to those of patients who also had epidurals, but without a dural puncture.
The investigators hypothesize that audiovisual complications occur more frequently in patients having accidental dural puncture with epidural needle and that the symptoms resolve with the administration of epidural blood patch.
详细描述
Although many studies have reported auditory complications after spinal, none have been done in obstetric patients with accidental dural puncture with epidural needle. Long term follow up of these complications has been unknown. The incidence of both auditory and visual complications is likely to be high in patients getting accidental dural puncture with 17G Touhy epidural needle as compared to small gauge spinal needles. Several case reports have been reported with such temporary and permanent hearing and visual loss. A prospective study to understand these complications is required. The study will provide us with the true incidence of audiovisual complications of dural puncture with an epidural needle. Early intervention in cases of dural puncture may alleviate or halt symptoms.
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
- 否
入选标准
- •Parturients having accidental dural puncture during epidural placement for labour analgesia.
- •Patients who give written informed consent to participate in the study.
- •Dural puncture with 17G Touhy needle with/out headache
- •Postural headache after 24 hours of epidural
- •Labouring women undergoing vaginal or Cesarean delivery
- •For the control group, patients with no dural puncture during epidural placement
- •Exclusion criteria:
- •Patients refusing to consent
- •Dural puncture with spinal needle
排除标准
- 未提供
结局指标
主要结局
Hearing loss
时间窗: 1 month
Hearing loss as measured by audiometry
次要结局
- Severity of headache(1 month)
- Associated vestibular symptoms(1 month)
- Associated cochlear symptoms(1 month)
- Ocular symptoms(1 month)
- Musculoskeletal symptoms(1 month)