NCT03790124

Post-dural Puncture Headache: A Retrospective Study

Completed Last updated 19 June 2019

What this trial tests

trial in Obstetric Anesthesia Problems in 50 participants. Completed in 30 March 2019.

Timeline

1 February 2019

Primary endpoint
1 March 2019

30 March 2019

Quick facts

Lead sponsor	Augusta University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	50
Start date	1 February 2019
Primary completion	1 March 2019
Estimated completion	30 March 2019
Sites	1 location across United States

Conditions studied

• Obstetric Anesthesia Problems — all drugs for Obstetric Anesthesia Problems →
• Headache — all drugs for Headache →
• Epidural; Anesthesia, Headache — all drugs for Epidural; Anesthesia, Headache →

Sponsor

Augusta University

Who can join

18 and older, female only, with Obstetric Anesthesia Problems or Headache. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.