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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Procedure: Audiometry

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women having epidural analgesia for labour pain management.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with dural puncture at epidural; Patients who sustained an accidental dural puncture during the epidural procedure.	Procedure: Audiometry; Other Names: hearing test
Patients with no dural puncture; Patients with no dural puncture during epidural procedure, to serve as a control group.	Procedure: Audiometry; Other Names: hearing test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing loss	Hearing loss as measured by audiometry	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Associated vestibular symptoms	The presence of nausea, vomiting, vertigo, dizziness, associated with the dural puncture headache.	1 month
Associated cochlear symptoms	The presence of hearing loss, hyperacusis or tinnitus, associated with the dural puncture headache.	1 month
Ocular symptoms	The presence of photophobia, teichopsia, diplopia or difficulty in accommodation, associated with the dural puncture headache.	1 month
Musculoskeletal symptoms	The presence of neck stiffness or scapular pain, associated with the dural puncture headache.	1 month

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 25, 2007
• Primary Completion (ACTUAL): February 18, 2010
• Study Completion (ACTUAL): April 30, 2010

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (ACTUAL): February 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: epidural; audiometry; dural puncture
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: 18-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No