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

Primary Purpose

Headache

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sphenopalatine ganglion Block
Epidural blood patch
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sphenopalatine Ganglion Block

Epidural blood patch

Arm 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 The swabs are withdrawn after 30 minutes.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2016
Last Updated
January 21, 2020
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02962427
Brief Title
Treatment of Post-dural Puncture Headache in Postpartum Patients: Sphenopalatine Ganglion Block to Epidural Blood Patch.
Official Title
Treatment of Post-dural Puncture Headache in Postpartum Parturients: Comparing Sphenopalatine Ganglion Block to Epidural Blood Patch.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Decided to participate in a multicenter trial researching the same issue
Study Start Date
November 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sphenopalatine Ganglion Block
Arm Type
Experimental
Arm 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.
Arm Title
Epidural blood patch
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Sphenopalatine ganglion Block
Other Intervention Name(s)
SGB
Intervention Type
Procedure
Intervention Name(s)
Epidural blood patch
Other Intervention Name(s)
EBP
Primary Outcome Measure Information:
Title
Change in The Numerical Rating Scale Pain Score
Description
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.
Time Frame
Baseline and 48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Age 18 years or age or greater Postpartum obstetric parturient who was previously admitted to UCH. Diagnosis of post-dural puncture headache based on the International Classification of Headache Disorders: Dural puncture has been performed Headache has developed within 5 days of the dural puncture Not better accounted for by another ICHD-3 diagnosis. Occurring immediately or within seconds of assuming an upright position and resolving quickly (within 1 minute) after lying horizontally. Exclusion Criteria Refusal to participate in the study Placement of an EBP within the past 5 days Allergy and/or intolerance to any the study materials Contraindications to an EBP Plan for therapeutic anticoagulation post-partum
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Wood, M.D.
Organizational Affiliation
University of Colorado Anschutz Medical Campus - School of Medicine, Dept. of Anesthheisology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not sharing IPD with other researchers

Learn more about this trial

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

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