Post-dural Puncture Headache: A Retrospective Study

• ClinicalTrials.gov Identifier: NCT03790124
• Recruitment Status: Completed
• First Posted: December 31, 2018
• Last Update Posted: June 19, 2019
• Sponsor: Augusta University
• Information provided by (Responsible Party): Efrain Riveros Perez, MD, Augusta University

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
Obstetric Anesthesia Problems; Headache; Epidural; Anesthesia, Headache

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: February 1, 2019
• Actual Primary Completion Date: March 1, 2019
• Actual Study Completion Date: March 30, 2019

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients who underwent labor epidural analgesia and had accidental dural puncture (wet tap)

Criteria

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

United States, Georgia

Augusta University

Augusta, Georgia, United States, 30912

Sponsors and Collaborators

Augusta University

More Information

• Responsible Party: Efrain Riveros Perez, MD, Assistant Professor. Department of Anesthesiology, Augusta University
• ClinicalTrials.gov Identifier: NCT03790124
• Other Study ID Numbers: 1218545
• First Posted: December 31, 2018
• Last Update Posted: June 19, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• 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:

Post-Dural Puncture Headache; Headache; Pain; Neurologic Manifestations; Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases