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Alteration in Hearing Following Accidental Dural Puncture. A Study in Parturients (AHEAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01682967
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : September 29, 2015
Karolinska Institutet
Information provided by (Responsible Party):
Anil Gupta, Örebro University, Sweden

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.

Condition or disease
Parturients in Labour

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.

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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Alteration in Hearing Following Accidental Dural Puncture. A Study in Parturients
Study Start Date : January 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Experimental group
Patients suffering from PDPH would form this group
Control group - Epidural
Patients who received an epidural during labour but did not have symptoms of PDPH would form this reference group
Control Group without Epidural analgesia
Patients in labour who did not receive an EDA would form this cohort of controls

Primary Outcome Measures :
  1. Post-dural puncture headache [ Time Frame: 4 h after epidural blood patch ]
    VAS pain (headache) 4 h after application of EBP

Secondary Outcome Measures :
  1. Audiometric data [ Time Frame: 4 h following EBP ]
    OAE and ASSR would be measured 4 h after application of EBP

  2. 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

  3. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Experimental group: Parturients in labour with epidural and having PDPH Control group - EDA: Parturients in labour with epidural and NOT having PDPH Control group - No EDA: Parturients in labour without epidural and NOT having PDPH

Inclusion Criteria:

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

Exclusion Criteria:

  • Taking steroid medication Having pre-eclampsia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01682967

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Solna, Sweden
University Hospital
Örebro, Sweden, 701 85
Sponsors and Collaborators
Örebro University, Sweden
Karolinska Institutet

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Responsible Party: Anil Gupta, Associate Professor, Örebro University, Sweden Identifier: NCT01682967     History of Changes
Other Study ID Numbers: AHEAD-11
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015

Keywords provided by Anil Gupta, Örebro University, Sweden:
Analgesia, epidural
Headache, post-dural puncture