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

Phase 4

Terminated

• Conditions: Headache
• Interventions: Drug: Sphenopalatine ganglion Block; Procedure: Epidural blood patch

• Registration Number: NCT02962427
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-09
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-11
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Results First Submitted: 2019-09-24
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-21
• Last Update Submitted: 2020-01-21
• Results First Posted: 2020-01-23
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Sphenopalatine Ganglion Block	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 The swabs are withdrawn after 30 minutes.
Epidural blood patch	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.

Primary Outcome Measures

Name	Time	Method
Change in The Numerical Rating Scale Pain Score	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.

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States