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

Parturients in Labour Clinical Trial

— AHEAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682967
• Other study ID #: AHEAD-11
• Status: Completed
• Phase: N/A
• First received: September 7, 2012
• Last updated: September 26, 2015
• Start date: January 2012
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: University Hospital, Örebro, Sweden:
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Taking steroid medication Having pre-eclampsia

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parturients in Labour

Locations

Country	Name	City	State
Sweden	University Hospital	Örebro
Sweden	Karolinskasjukhuset	Solna

Sponsors (2)

Lead Sponsor	Collaborator
Örebro University, Sweden	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-dural puncture headache	VAS pain (headache) 4 h after application of EBP	4 h after epidural blood patch	No
Secondary	Audiometric data	OAE and ASSR would be measured 4 h after application of EBP	4 h following EBP	No
Secondary	PDPH questionnaire	The PDPH questionnaire would be used to analyse pain and its characteristics 4 h after application of EBP	4 h after application of EBP	No
Secondary	Recurrence of Headache	The incidence of recurrence of PDPH after initial improvement on application of EBP would be recorded after 24 h	24 h after application of EBP	No