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NCT Number: NCT03790124

Post-dural Puncture Headache: A Retrospective Study

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Augusta University

Augusta, Georgia, 30912, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of cases with Postdural puncture headache

    Time frame: 3 days after delivery

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

Secondary outcomes

  1. Number of cases of epidural patch placement

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

Effectiveness of a Multimodal Prophylactic Strategy to Treat Post-dural Puncture Headache: A Retrospective Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 31, 2018
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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