Clinical trial NCT03428841: Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients
Official title: Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Keywords: audiometry
dural puncture
epidural
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women having epidural analgesia for labour pain management.

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.

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

Primary outcomes:
measure: Hearing loss
timeFrame: 1 month
Secondary outcomes:
measure: Severity of headache
timeFrame: 1 month
measure: Associated vestibular symptoms
timeFrame: 1 month
measure: Associated cochlear symptoms
timeFrame: 1 month
measure: Ocular symptoms
timeFrame: 1 month
measure: Musculoskeletal symptoms
timeFrame: 1 month
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Mrinalini Balki, MD
role: PRINCIPAL_INVESTIGATOR
References: