Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients

NCT03428841 | Completed

• 1 other identifier: 18-02
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Keywords

audiometry; dural puncture; epidural

Outcome Measures

Primary Outcomes (1)

• Hearing loss

  Hearing loss as measured by audiometry

  1 month

Secondary Outcomes (5)

• Severity of headache

  1 month

• Associated vestibular symptoms

  1 month

• Associated cochlear symptoms

  1 month

• Ocular symptoms

  1 month

• Musculoskeletal symptoms

  1 month

Study Arms (2)

Patients with dural puncture at epidural

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

Procedure: Audiometry

Patients with no dural puncture

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

Procedure: Audiometry

Interventions

Audiometry PROCEDURE

Also known as: hearing test

Patients with dural puncture at epidural; Patients with no dural puncture

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women having epidural analgesia for labour pain management.

You may qualify if:

• 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

You may not qualify if:

• Patients refusing to consent
• Dural puncture with spinal needle

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vestibulocochlear Physiological Phenomena; Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mrinalini Balki, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 12, 2018
• Study Start: September 25, 2007
• Primary Completion: February 18, 2010
• Study Completion: April 30, 2010
• Last Updated: February 14, 2018

Record last verified: 2018-02

Locations

CA (1)