- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01682967
Alteration in Hearing Following Accidental Dural Puncture. A Study in Parturients (AHEAD)
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Solna, Sweden
- Karolinskasjukhuset
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Örebro, Sweden, 701 85
- University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy parturients No known hearing problems Understand Swedish language Informed consent
Exclusion Criteria:
- Taking steroid medication Having pre-eclampsia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Experimental group
Patients suffering from PDPH would form this group
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Control group - Epidural
Patients who received an epidural during labour but did not have symptoms of PDPH would form this reference group
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Control Group without Epidural analgesia
Patients in labour who did not receive an EDA would form this cohort of controls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-dural puncture headache
Time Frame: 4 h after epidural blood patch
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VAS pain (headache) 4 h after application of EBP
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4 h after epidural blood patch
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Audiometric data
Time Frame: 4 h following EBP
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OAE and ASSR would be measured 4 h after application of EBP
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4 h following EBP
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PDPH questionnaire
Time Frame: 4 h after application of EBP
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The PDPH questionnaire would be used to analyse pain and its characteristics 4 h after application of EBP
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4 h after application of EBP
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Recurrence of Headache
Time Frame: 24 h after application of EBP
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The incidence of recurrence of PDPH after initial improvement on application of EBP would be recorded after 24 h
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24 h after application of EBP
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AHEAD-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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