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

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ClinicalTrials.gov Identifier: NCT02962427
Recruitment Status : Unknown
Verified November 2016 by University of Colorado, Denver.
Recruitment status was:  Recruiting
First Posted : November 11, 2016
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Headache Drug: Sphenopalatine ganglion Block Procedure: Epidural blood patch Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Post-dural Puncture Headache in Postpartum Parturients: Comparing Sphenopalatine Ganglion Block to Epidural Blood Patch.
Study Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sphenopalatine Ganglion Block
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.
Drug: Sphenopalatine ganglion Block
Other Name: SGB

Active Comparator: Epidural blood patch
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.
Procedure: Epidural blood patch
Other Name: EBP




Primary Outcome Measures :
  1. Change in The Numerical Rating Scale Pain Score [ Time Frame: Baseline and 48 hours ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962427


Contacts
Contact: Colleen K Dingmann, R.N., Ph.D. 303-724-7494 colleen.dingmann@comcast.net

Locations
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Colleen Dingmann, R.N., Ph.D.    303-724-7494    colleen.dingmann@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Cristina Wood, M.D. University of Colorado Anschutz Medical Campus - School of Medicine, Dept. of Anesthheisology

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02962427     History of Changes
Other Study ID Numbers: 16-1596
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not sharing IPD with other researchers

Additional relevant MeSH terms:
Headache
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases