Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

May 20, 2022 updated by: Verghese T Cherian, MD, Milton S. Hershey Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Score at Baseline
Time Frame: 15 minutes before the SP block
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
Time Frame: 60 minutes
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
Time Frame: 1 day
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
Time Frame: 2 days
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
Time Frame: 7 days
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
Time Frame: 30 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Pain Relief
Time Frame: 24 hours
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
Time Frame: 7 days
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
Time Frame: 15 minutes before the SP block to 30 days post SP 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Verghese Cherian, MD, Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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