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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01682967
Acronym
AHEAD
Enrollment
21
Registered
2012-09-11
Start date
2012-01-31
Completion date
2015-09-30
Last updated
2015-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parturients in Labour

Keywords

Parturients, Analgesia, epidural, Headache, post-dural puncture

Brief summary

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.

Detailed description

Parturients who have received epidural analgesia during labour would be included in this study and these would comprise of: 1. patients without clinical symptoms of postdural puncture headache 2. 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.

Interventions

None listed

Sponsors

Karolinska Institutet
CollaboratorOTHER
Örebro University, Sweden
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy parturients No known hearing problems Understand Swedish language Informed consent

Exclusion criteria

* Taking steroid medication Having pre-eclampsia

Design outcomes

Primary

MeasureTime frameDescription
Post-dural puncture headache4 h after epidural blood patchVAS pain (headache) 4 h after application of EBP

Secondary

MeasureTime frameDescription
Audiometric data4 h following EBPOAE and ASSR would be measured 4 h after application of EBP
PDPH questionnaire4 h after application of EBPThe PDPH questionnaire would be used to analyse pain and its characteristics 4 h after application of EBP
Recurrence of Headache24 h after application of EBPThe incidence of recurrence of PDPH after initial improvement on application of EBP would be recorded after 24 h

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026