Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache; A Pilot Study

The objective of the study is to determine the effectiveness of Spheno-Palatine (SP) ganglion block to alleviate the pain of post-dural puncture headache (PDPH).

Study Overview

• Status: Terminated
• Conditions: Post-Dural Puncture Headache; Sphenopalatine Ganglion Block
• Intervention / Treatment: Drug: Lidocaine

Detailed Description

The primary objectives of the study are to study the effectiveness of SP ganglion block in relieving post-dural puncture headache in terms of :

1. Number of subjects who get relief of pain
2. The onset time to pain relief after application of block
3. The duration of pain relief
4. The incidence of recurrence of post-dural puncture headache

Secondary objectives are to:

1. Monitor any complications due to SP ganglion block
2. Measure patient satisfaction
3. Monitor any residual effects at 1 months after the SP block

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Complains of symptoms suggestive of post-dural puncture headache
2. Has a history of dural puncture (lumbar puncture or accidental dural puncture during epidural placement) within the previous 7 days
3. Fluent in written and spoken English

Exclusion Criteria:

1. Those with a known history of hypersensitivity to local anesthetics of the amide type or to other components of GLYDO
2. Those with any congenital or acquired, anatomical deformity of the nostril, which preclude performing the block
3. Those who refuse to consent to participate in the study
4. Patients who have had a failed epidural blood patch
5. Cognitive Impairment
6. Prisoner

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sphenopalatine ganglion block; Sphenopalatine ganglion block: this block will be performed by inserting swabs, with lidocaine squirted on them, into each nostril and reaching the nasopharyngeal wall.

Drug: Lidocaine; Lidocaine 2% viscous (0.5ml) will be squirted on two cotton swab sticks and one will be gently inserted into each nostril, along the floor of the nose. Slight rotatory motion of the stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab sticks will be left undisturbed for 5 minutes. The swabs will be taken out and this will be repeated twice more, using fresh swabs and 0.5ml of 2% lidocaine. The block would take about 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score at Baseline	Pain scores will be recorded at Baseline in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.	15 minutes before the SP block
Pain Score 60 Minutes Post-SP Block	Pain scores will be recorded 60 minutes post-SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.	60 minutes
Pain Score 1 Day Post-SP Block	Patient reported pain scores will be recorded day 1 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.	1 day
Pain Score 2 Days Post-SP Block	Patient reported pain scores will be recorded day 2 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.	2 days
Pain Score 7 Days Post-SP Block	Patient reported pain scores will be recorded day 7 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.	7 days
Pain Score 30 Day Post-SP Block	Patient reported pain scores will be recorded day 30 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Pain Relief	Patient reported how long after the SP block the patient reported pain scores that were decreased form the baseline measures. The outcome measure is measured in hours that pain relief was achieved.	24 hours
Number of Participants With Recurrence of Post-dural Puncture Headache	Patient reported recurrence of post dural puncture headache resulting in treatment with epidural blood patch	7 days
Number of Participants With Complications Due to SP Ganglion Block	Patients will be asked to report any side effects, including: allergic reaction to lidocaine, nose irritation and nose-bleed.	15 minutes before the SP block to 30 days post SP block

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Verghese Cherian, MD, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2019
• Primary Completion (Actual): January 16, 2020
• Study Completion (Actual): March 11, 2022

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Pain; Neurologic Manifestations; Cysts; Connective Tissue Diseases; Mucinoses; Headache Disorders; Headache Disorders, Secondary; Headache; Ganglion Cysts; Synovial Cyst; Post-Dural Puncture Headache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 8426 (Duke legacy protocol number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No