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

NCT02962427 | Terminated Phase 4 Results

• 1 other identifier: 16-1596
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sphenopalatine Ganglion Block

EXPERIMENTAL

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 The swabs are withdrawn after 30 minutes.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

Epidural blood patch

ACTIVE COMPARATOR

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

Interventions

Sphenopalatine ganglion Block DRUG

Also known as: SGB

Sphenopalatine Ganglion Block

Epidural blood patch PROCEDURE

Also known as: EBP

Epidural blood patch

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Headache

Interventions

Sphenopalatine Ganglion Block; Blood Patch, Epidural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Biological Therapy; Therapeutics; Injections, Epidural; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy

Results Point of Contact

• Title: Cristina Wood, MD
• Organization: University of Colorado

cristina.wood@ucdenver.edu

7208483323

Study Officials

• Cristina Wood, M.D.

  University of Colorado Anschutz Medical Campus - School of Medicine, Dept. of Anesthheisology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 11, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 23, 2020
• Results First Posted: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)