Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients

Hearing Loss Clinical Trial

Official title:

Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03428841
• Other study ID #: 18-02
• Status: Completed
• Phase: N/A
• First received: February 5, 2018
• Last updated: February 12, 2018
• Start date: September 25, 2007
• Est. completion date: April 30, 2010

Study information

• Verified date: February 2018
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 30, 2010
• Est. primary completion date: February 18, 2010
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Procedure:
• Audiometry

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hearing loss	Hearing loss as measured by audiometry	1 month
Secondary	Severity of headache	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.	1 month
Secondary	Associated vestibular symptoms	The presence of nausea, vomiting, vertigo, dizziness, associated with the dural puncture headache.	1 month
Secondary	Associated cochlear symptoms	The presence of hearing loss, hyperacusis or tinnitus, associated with the dural puncture headache.	1 month
Secondary	Ocular symptoms	The presence of photophobia, teichopsia, diplopia or difficulty in accommodation, associated with the dural puncture headache.	1 month
Secondary	Musculoskeletal symptoms	The presence of neck stiffness or scapular pain, associated with the dural puncture headache.	1 month