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

• ClinicalTrials.gov Identifier: NCT02962427
• Recruitment Status: Recruiting
• First Posted: November 11, 2016
• Last Update Posted: December 27, 2018
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

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.

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 Design

• 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: March 2019
• Estimated Study Completion Date: November 2019

Arms and Interventions

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 The swabs are withdrawn after 30 minutes.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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT02962427 History of Changes
• Other Study ID Numbers: 16-1596
• First Posted: November 11, 2016
• Last Update Posted: December 27, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Not sharing IPD with other researchers

Additional relevant MeSH terms:

Post-Dural Puncture Headache; Headache; Pain; Neurologic Manifestations; Signs and Symptoms; Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases