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Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

Primary Purpose

Post-Dural Puncture Headache, Sphenopalatine Ganglion Block

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Dural Puncture Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sphenopalatine ganglion block

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
February 6, 2018
Last Updated
May 20, 2022
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03430531
Brief Title
Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache
Official Title
Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache; A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Study suspended and subsequently terminated due to Pandemic
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
January 16, 2020 (Actual)
Study Completion Date
March 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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 : Number of subjects who get relief of pain The onset time to pain relief after application of block The duration of pain relief The incidence of recurrence of post-dural puncture headache Secondary objectives are to: Monitor any complications due to SP ganglion block Measure patient satisfaction Monitor any residual effects at 1 months after the SP block

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Dural Puncture Headache, Sphenopalatine Ganglion Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open-label, single arm, pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sphenopalatine ganglion block
Arm Type
Experimental
Arm Description
Sphenopalatine ganglion block: this block will be performed by inserting swabs, with lidocaine squirted on them, into each nostril and reaching the nasopharyngeal wall.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Score at Baseline
Description
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.
Time Frame
15 minutes before the SP block
Title
Pain Score 60 Minutes Post-SP Block
Description
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.
Time Frame
60 minutes
Title
Pain Score 1 Day Post-SP Block
Description
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.
Time Frame
1 day
Title
Pain Score 2 Days Post-SP Block
Description
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.
Time Frame
2 days
Title
Pain Score 7 Days Post-SP Block
Description
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.
Time Frame
7 days
Title
Pain Score 30 Day Post-SP Block
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Duration of Pain Relief
Description
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.
Time Frame
24 hours
Title
Number of Participants With Recurrence of Post-dural Puncture Headache
Description
Patient reported recurrence of post dural puncture headache resulting in treatment with epidural blood patch
Time Frame
7 days
Title
Number of Participants With Complications Due to SP Ganglion Block
Description
Patients will be asked to report any side effects, including: allergic reaction to lidocaine, nose irritation and nose-bleed.
Time Frame
15 minutes before the SP block to 30 days post SP block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Complains of symptoms suggestive of post-dural puncture headache Has a history of dural puncture (lumbar puncture or accidental dural puncture during epidural placement) within the previous 7 days Fluent in written and spoken English Exclusion Criteria: Those with a known history of hypersensitivity to local anesthetics of the amide type or to other components of GLYDO Those with any congenital or acquired, anatomical deformity of the nostril, which preclude performing the block Those who refuse to consent to participate in the study Patients who have had a failed epidural blood patch Cognitive Impairment Prisoner
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Verghese Cherian, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

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