Post-dural Puncture Headache: A Retrospective Study

Sponsor
Augusta University (Other)
Overall Status
Completed
CT.gov ID
NCT03790124
Collaborator
(none)
50
1
1.9
26.7

Study Details

Study Description

Brief Summary

Neuraxial techniques are widely used in obstetric practice to provide analgesia and anesthesia. A common complication associated with neuraxial anesthesia is post-dural puncture headache (PDPH), resulting from unintentional or unintended puncture of the dura mater during insertion of an epidural needle. Incidence of PDPH after spinal anesthesia is very low due to the widespread use of non-cutting small diameter spinal needles. Incidence of "wet tap" during epidural injection has been reported to be 1.5%, with 52-85% of these patients developing PDPH.

When an obstetric patient develops PDPH, institution of an effective treatment is necessary. Although PDPH tends to resolve spontaneously over a couple of weeks, it carries the risk of potential complications. PDPH interfere with the ability of the mother to take care of her baby, increases the risk of chronic headache and limits early ambulation, thereby increasing the risk of venous thrombosis and pulmonary embolism. As important as treating PDPH when it occurs is to prevent it when the dura is accidentally punctured during labor epidural placement. Multiple therapeutic strategies have been reported in the medical literature to prevent this outcome. Preventive measures range from conservative strategies to invasive procedures. Bedrest and hydration have been traditionally recommended to try to prevent PDPH when a wet tap occurs; however, no conclusive evidence supports their use. The use of oral and intravenous caffeine is insufficiently supported by clinical evidence. Epidural morphine and intravenous cosyntropin have been successfully used to prevent PDPH. Epidural injection of normal saline reduces the gradient for CSF leak. The use of saline has shown variable results in different studies. Although the results of some studies show insufficient evidence about its effectiveness, administration of epidural saline is a technique relatively devoid of significant adverse effects.

The institutional protocol recommends the combination of a multimodal approach to prevention of PDPH after accidental dural puncture, based on strategies reported in the medical literature. The protocol consists of the immediate administration of 60 cc of epidural normal saline, followed by two preventive measures administered after delivery. After delivery, 1 mg of intravenous cosyntropin and 3 mg of epidural morphine before catheter removal are administered. This study tests the hypothesis that the multimodal prophylactic protocol described above decreases the incidence of PDPH and the need to perform epidural blood patch, compared to other strategies or no prophylactic management.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Effectiveness of a Multimodal Prophylactic Strategy to Treat Post-dural Puncture Headache: A Retrospective Study
    Actual Study Start Date :
    Feb 1, 2019
    Actual Primary Completion Date :
    Mar 1, 2019
    Actual Study Completion Date :
    Mar 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Number of cases with Postdural puncture headache [3 days after delivery]

      Number of patients who had wet tap during epidural placement who developed postdural puncture headache

    Secondary Outcome Measures

    1. Number of cases of epidural patch placement [3 days after delivery]

      Number of patients who had wet tap during epidural placement who developed postdural puncture and required performance of epidural blood patch

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Pregnant patients who underwent labor epidural and had accidental dural puncture
    Exclusion Criteria:
    • History of migraines or chronic headaches

    • History of neurological deficits

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Augusta University Augusta Georgia United States 30912

    Sponsors and Collaborators

    • Augusta University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Efrain Riveros Perez, MD, Assistant Professor. Department of Anesthesiology, Augusta University
    ClinicalTrials.gov Identifier:
    NCT03790124
    Other Study ID Numbers:
    • 1218545
    First Posted:
    Dec 31, 2018
    Last Update Posted:
    Jun 19, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 19, 2019