Alteration in Hearing Following Accidental Dural Puncture. A Study in Parturients

Headache following accidental dural punction as during epidural analgesia can be severe and sometimes very disabling. The incidence of PDPH is 10-40%, most starting within 48 h of dural puncture. Although spontaneous resolution of headaches is common in most patients within 7 days, in 20% can they be persistent and in some very disabling. The exact reason for the characteristic headache is unknown, but it is believed to be the result of leakage of cerebro-spinal fluid (CSF) from the dural puncture. The greater the leakage of CSF, the more severe and persistent the headache. This is why larger needles (lower gauge) are known to have a higher incidence of PDPH. However, the type of needle also seems to play an important role in the likelihood of PDPH.

Headache following accidental PDPH is very typical as it increases significantly when sitting or standing and often disappears completely on lying down. It is typically located in the back of the head, accentuated by light and often decreases with intake of large quantity of fluids. In many cases, it is self-limiting and most often decreases with time and bed rest.

Diagnosis of PDPH is clinical and sometimes difficult. It is well known that liquor leakage, as following spinal anaesthesia, results in partial loss of unilateral or bilateral hearing that can be detected by oto-acoustic hearing loss. We plan to use this knowledge and test the hypothesis that measurement of hearing loss may be a diagnostic method for confirmation of clinical symptoms and signs of accidental PDPH.

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Key information

Conditions

Parturients in Labour Agnosia Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Post-Dural Puncture Headache Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Karolinskasjukhuset, Solna, Sweden

About this study

Parturients who have received epidural analgesia during labour would be included in this study and these would comprise of:

patients without clinical symptoms of postdural puncture headache
patients with clinical symptoms of postdural puncture headache

In addition, a control group of parturients who have not received an epidural analgesia would constitute the control group.

All patients would have audiometry (oto-acoustic emission - OAE, and auditory steady state response - ASSR) done following diagnosis of PDPH. Subsequently, the patients would be observed for 24 h to assess whether the headache resolves spontaneously. A new audiometry would be done at this stage. Those patients with substantial evidence of PDPH at this stage would receive an epidural blood patch (EBP) and a new audiometric assessment would be made after 4 h and 24 h to assess whether any audiometric deficit has resolved or not. All patients would have a similar measurement of hearing after 3 months when it is believed that most patients have returned to normal hearing. In addition to audiometric analysis, patients would be asked to fill out a detailed PDPH questionnaire at the same time periods.

All measurements would be compared with patients who have received an EDA but without PDPH and those who have not received an EDA.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy parturients No known hearing problems Understand Swedish language Informed consent

Exclusion criteria

Taking steroid medication Having pre-eclampsia

Treatment and study plan

Primary outcomes

Post-dural puncture headache

Time frame: 4 h after epidural blood patch

VAS pain (headache) 4 h after application of EBP

Secondary outcomes

Audiometric data

Time frame: 4 h following EBP

OAE and ASSR would be measured 4 h after application of EBP
PDPH questionnaire

Time frame: 4 h after application of EBP

The PDPH questionnaire would be used to analyse pain and its characteristics 4 h after application of EBP
Recurrence of Headache

Time frame: 24 h after application of EBP

The incidence of recurrence of PDPH after initial improvement on application of EBP would be recorded after 24 h

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

Karolinska Institutet

Registry information

Acronym: AHEAD

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Sep 11, 2012
Registry last updated: Sep 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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