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Completed

NCT Number: NCT03428841

Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Audiometry

Procedure

Other names: hearing test

Primary outcomes

  1. Hearing loss

    Time frame: 1 month

    Hearing loss as measured by audiometry

Secondary outcomes

  1. Severity of headache

    Time frame: 1 month

    Pain from postdural puncture headache, rated on verbal numeric rating scale (VNRS) from 0-10, where 0 represents no pain and 10 represents worst pain.

  2. Associated vestibular symptoms

    Time frame: 1 month

    The presence of nausea, vomiting, vertigo, dizziness, associated with the dural puncture headache.

  3. Associated cochlear symptoms

    Time frame: 1 month

    The presence of hearing loss, hyperacusis or tinnitus, associated with the dural puncture headache.

  4. Ocular symptoms

    Time frame: 1 month

    The presence of photophobia, teichopsia, diplopia or difficulty in accommodation, associated with the dural puncture headache.

  5. Musculoskeletal symptoms

    Time frame: 1 month

    The presence of neck stiffness or scapular pain, associated with the dural puncture headache.

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 12, 2018
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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