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

University of Colorado Denver (CU Denver)

Status and phase: Terminated; Phase 4

Conditions: Headache

Treatments: Procedure: Epidural blood patch; Drug: Sphenopalatine ganglion Block

Study type: Interventional

Funder types: Other

Identifiers

NCT02962427

16-1596

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Sphenopalatine Ganglion Block

Experimental group

Description:

Sphenopalatine Ganglion Block: The patient is placed in the supine position. Four cc of 2% viscous lidocaine is placed to the level of the sphenopalatine ganglion with a 20 gauge angiocatheter along sterile swabs which were placed carefully into the patients nostrils bilaterally and lateral to the middle turbinate. It will be documented that the patient has no pain or paresthesia during or after the procedure. The swabs are withdrawn after 30 minutes.

Treatment:

Drug: Sphenopalatine ganglion Block

Epidural blood patch

Active Comparator group

Description:

Epidural Blood Patch: The patient is positioned in the sitting or lateral positon. Using aseptic technique, 20mL of autologous blood is drawn by a trained practitioner. The epidural placement is performed by a trained practitioner using aseptic technique and the vertebral space accessed is at or immediately below the original neuraxial placement. After entrance into the epidural space is confirmed with loss of resistance technique to either air or saline, 15-20 milliliters of sterile autologous venous blood is injected. After the procedure the patient rests supine for at least 1 hour. Patients are instructed to avoid heavy lifting, abdominal straining, or coughing for at least 48 hours.

Treatment:

Procedure: Epidural blood patch