Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)

NCT02365909 | Terminated Early Phase 1 DMC

• 1 other identifier: 203684
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Postdural puncture headaches (PDPH) are a consequence of spinal and epidural anesthesia in approximately 1% of cases when performed in obstetric patients. The gold standard treatment for a PDPH is currently an epidural blood patch (EBP), which involves placing a needle back into the epidural space of the neuraxium and then injecting 20 ml of the patient's own blood through the needle and into the epidural space to form a clot over the insult in the tissue layer that causes the headaches. The investigators want to test the efficacy of using a less invasive procedure, called a sphenopalatine block (SPGB), for treatment of PDPH. SPGB has been used for many years in the treatment of migraines and cluster headaches, and there are several case reports of its use to successfully treat PDPH as well. SPGB simply involves applying a local anesthetic to the mucosa in the back of each nostril to numb the nerves that cause the headache. The investigators hope that the SPGB will reduce the number of PDPH patients that require and EBP.

Conditions

Postdural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• Headache verbal pain score

  1 hour

Study Arms (2)

Acitve

ACTIVE COMPARATOR

This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®

Drug: 0.5% bupivacaine

Placebo

PLACEBO COMPARATOR

This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®

Drug: normal saline

Interventions

0.5% bupivacaine DRUG

This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®

Acitve

normal saline DRUG

This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active postdural puncture headache within 7 days after neuraxial analgesia/anesthesia
• Age ≥ 18 years.
• ASA physical status ≤ 3

You may not qualify if:

• Known coagulopathy
• Known nasal septal deviation or abnormalities
• Medical conditions contraindicated to bupivacaine or the nasal applicator (according to the product labeling)

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: February 19, 2015
• Study Start: June 29, 2015
• Primary Completion: August 30, 2016
• Study Completion: August 30, 2016
• Last Updated: September 18, 2017

Record last verified: 2017-09

Locations

US (1)