Treatment of Post-dural Puncture Headache in Postpartum Patients: Sphenopalatine Ganglion Block to Epidural Blood Patch.

Headache Clinical Trial

Official title:

Treatment of Post-dural Puncture Headache in Postpartum Parturients: Comparing Sphenopalatine Ganglion Block to Epidural Blood Patch.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02962427
• Other study ID #: 16-1596
• Status: Terminated
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: December 2018

Study information

• Verified date: January 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to compare the effectiveness of a sphenopalatine ganglion block to an epidural blood patch for post-dural puncture headache relief in randomized postpartum parturients over a 48 hour period.

Description:

The purpose of this research study is to compare the effectiveness of a sphenopalatine ganglion block to an epidural blood patch for post-dural puncture headache relief in randomized postpartum parturients over a 48 hour period. A known dural puncture is defined as free flow of cerebral spinal fluid (CSF) during neuraxial placement. An unknown dural puncture is defined as neuraxial placement where free flow of CSF is not appreciated, however the patient is diagnosed with a post-dural puncture headache as defined by the International Classification of Headache Disorders.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria

1. Age 18 years or age or greater

2. Postpartum obstetric parturient who was previously admitted to UCH.

3. Diagnosis of post-dural puncture headache based on the International Classification of Headache Disorders:

1. Dural puncture has been performed

2. Headache has developed within 5 days of the dural puncture

3. Not better accounted for by another ICHD-3 diagnosis.

4. Occurring immediately or within seconds of assuming an upright position and resolving quickly (within 1 minute) after lying horizontally.

Exclusion Criteria

1. Refusal to participate in the study

2. Placement of an EBP within the past 5 days

3. Allergy and/or intolerance to any the study materials

4. Contraindications to an EBP

5. Plan for therapeutic anticoagulation post-partum

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache

Intervention

Drug:
• Sphenopalatine ganglion Block

Procedure:
• Epidural blood patch

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in The Numerical Rating Scale Pain Score	The Numerical Rating Scale (NRS) is commonly used to evaluate pain level in patients. It is presented as a numerical scale of 11 options, numbered 0-10, where the patient's pain intensity is represented by a number between the extremes of 0 = no pain at all to 10 = worst pain imaginable in numerical fashion. Its simplicity, reliability, and validity have made the NRS a useful tool for describing pain severity or intensity. The Investigators will consider a difference of 20% as a clinically significant change in pain score.	Baseline and 48 hours