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Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients

Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03428841
Enrollment
50
Registered
2018-02-12
Start date
2007-09-25
Completion date
2010-04-30
Last updated
2018-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

audiometry, dural puncture, epidural

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREAudiometry

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Hearing loss1 monthHearing loss as measured by audiometry

Secondary

MeasureTime frameDescription
Severity of headache1 monthPain from postdural puncture headache, rated on verbal numeric rating scale (VNRS) from 0-10, where 0 represents no pain and 10 represents worst pain.
Associated vestibular symptoms1 monthThe presence of nausea, vomiting, vertigo, dizziness, associated with the dural puncture headache.
Associated cochlear symptoms1 monthThe presence of hearing loss, hyperacusis or tinnitus, associated with the dural puncture headache.
Ocular symptoms1 monthThe presence of photophobia, teichopsia, diplopia or difficulty in accommodation, associated with the dural puncture headache.
Musculoskeletal symptoms1 monthThe presence of neck stiffness or scapular pain, associated with the dural puncture headache.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026