Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients

NCT ID: NCT03428841

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-25
• Study Completion Date: 2010-04-30

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.

Conditions

Hearing Loss

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with dural puncture at epidural

Patients who sustained an accidental dural puncture during the epidural procedure.

Audiometry

Intervention Type: PROCEDURE

Patients with no dural puncture

Patients with no dural puncture during epidural procedure, to serve as a control group.

Audiometry

Intervention Type: PROCEDURE

Interventions

Audiometry

Intervention Type: PROCEDURE

Other Intervention Names

hearing test

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mrinalini Balki, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

18-02

Identifier Type: -

Identifier Source: org_study_id