Hearing LossNCT03428841
Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients
An observational study of Hearing Loss, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Audiometry
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 25 Sep 2007to 30 Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Study population: Women having epidural analgesia for labour pain management.
Who may be able to join
- 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
Who cannot join
- Patients refusing to consent
- Dural puncture with spinal needle
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Audiometry
- Keywords
- audiometry, dural puncture, epidural
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AudiometryProcedure or surgery
Also called hearing test
| Study group | Role | What they receive |
|---|---|---|
| Patients with dural puncture at epidural | Patients who sustained an accidental dural puncture during the epidural procedure. Receives: Procedure: Audiometry | |
| Patients with no dural puncture | Patients with no dural puncture during epidural procedure, to serve as a control group. Receives: Procedure: Audiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing loss
Hearing loss as measured by audiometry
Measured: 1 month
Secondary outcomes (5)
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.
Measured: 1 month
Associated vestibular symptoms
The presence of nausea, vomiting, vertigo, dizziness, associated with the dural puncture headache.
Measured: 1 month
Associated cochlear symptoms
The presence of hearing loss, hyperacusis or tinnitus, associated with the dural puncture headache.
Measured: 1 month
Ocular symptoms
The presence of photophobia, teichopsia, diplopia or difficulty in accommodation, associated with the dural puncture headache.
Measured: 1 month
Musculoskeletal symptoms
The presence of neck stiffness or scapular pain, associated with the dural puncture headache.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start25 Sep 2007
- Primary completion18 Feb 2010
- Study completion30 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mrinalini Balki, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428841
- Sponsor's protocol ID
- 18-02
- Status last verified
- Feb 2018
- First submitted
- 5 Feb 2018
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients
- ClinicalTrials.gov ID
- NCT03428841
- Acronym / sponsor ID
- 18-02
- Conditions
- Hearing Loss
- Keywords
- audiometry, dural puncture, epidural
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 25 Sep 2007 (actual)
- Primary completion
- 18 Feb 2010 (actual)
- Study completion
- 30 Apr 2010 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with dural puncture at epidural | – | Procedure: AudiometryPatients who sustained an accidental dural puncture during the epidural procedure. |
| Patients with no dural puncture | – | Procedure: AudiometryPatients with no dural puncture during epidural procedure, to serve as a control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women having epidural analgesia for labour pain management.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients refusing to consent
- Dural puncture with spinal needle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AudiometryAlso: hearing test | Procedure or surgery | Patients with dural puncture at epidural, Patients with no dural puncture |
Primary outcome
Hearing loss
Time frame: 1 month
Hearing loss as measured by audiometry
5 secondary outcomes
Severity of headache
Time frame: 1 month
Associated vestibular symptoms
Time frame: 1 month
Associated cochlear symptoms
Time frame: 1 month
Ocular symptoms
Time frame: 1 month
Musculoskeletal symptoms
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mrinalini Balki, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing loss (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.