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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Örebro University, Sweden
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Anil Gupta, Örebro University, Sweden
ClinicalTrials.gov Identifier:
NCT01682967
First received: September 7, 2012
Last updated: May 25, 2014
Last verified: May 2014
  Purpose

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
Parturients in Labour

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Alteration in Hearing Following Accidental Dural Puncture. A Study in Parturients

Resource links provided by NLM:


Further study details as provided by Örebro University, Sweden:

Primary Outcome Measures:
  • Post-dural puncture headache [ Time Frame: 4 h after epidural blood patch ] [ Designated as safety issue: No ]
    VAS pain (headache) 4 h after application of EBP


Secondary Outcome Measures:
  • Audiometric data [ Time Frame: 4 h following EBP ] [ Designated as safety issue: No ]
    OAE and ASSR would be measured 4 h after application of EBP

  • PDPH questionnaire [ Time Frame: 4 h after application of EBP ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The incidence of recurrence of PDPH after initial improvement on application of EBP would be recorded after 24 h


Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Taking steroid medication Having pre-eclampsia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682967

Locations
Sweden
Karolinskasjukhuset Recruiting
Solna, Sweden
Contact: Bijan Darvish, MD       bijan.darvish@karolinska.se   
Contact: Lars Irestedt, MD, PhD       lars.irestedt@karolinska.se   
Principal Investigator: Bijan Darvish, MD         
University Hospital Recruiting
Örebro, Sweden, 701 85
Contact: Anil Gupta, PhD    +46 19 6020256    anil.gupta@orebroll.se   
Contact: Andrea Perniola, MD    +46 19 6020303    andrea.perniola@orebroll.se   
Principal Investigator: Anil Gupta, MD, FRCA, PhD         
Sponsors and Collaborators
Örebro University, Sweden
Karolinska Institutet
  More Information

No publications provided

Responsible Party: Anil Gupta, Associate Professor, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT01682967     History of Changes
Other Study ID Numbers: AHEAD-11
Study First Received: September 7, 2012
Last Updated: May 25, 2014
Health Authority: University Hospital, Örebro, Sweden:

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

ClinicalTrials.gov processed this record on July 28, 2014