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Clinical Trials/NCT03428841
NCT03428841
Completed
Not Applicable

Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients

Samuel Lunenfeld Research Institute, Mount Sinai Hospital1 site in 1 country50 target enrollmentSeptember 25, 2007
ConditionsHearing Loss

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Enrollment
50
Locations
1
Primary Endpoint
Hearing loss
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 25, 2007
End Date
April 30, 2010
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Hearing loss

Time Frame: 1 month

Hearing loss as measured by audiometry

Secondary Outcomes

  • Severity of headache(1 month)
  • Associated vestibular symptoms(1 month)
  • Associated cochlear symptoms(1 month)
  • Ocular symptoms(1 month)
  • Musculoskeletal symptoms(1 month)

Study Sites (1)

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