Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

Phase 2

Terminated

Conditions: Post-Dural Puncture Headache
Sphenopalatine Ganglion Block

Interventions: Drug: Lidocaine

Registration Number: NCT03430531

Lead Sponsor: Milton S. Hershey Medical Center

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 :

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

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 6

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pain Score 60 Minutes Post-SP Block	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.
Pain Score at Baseline	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.
Pain Score 1 Day Post-SP Block	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.
Pain Score 2 Days Post-SP Block	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.
Pain Score 7 Days Post-SP Block	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.
Pain Score 30 Day Post-SP Block	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Pain Relief	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.
Number of Participants With Recurrence of Post-dural Puncture Headache	7 days	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	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.