Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Post-Dural Puncture Headache, Sphenopalatine Ganglion Block

Intervention / Treatment
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* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label, single arm, pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sphenopalatine ganglion block<br>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<br>* 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.<br>|

What is the study measuring?
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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 |