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Study suspended and subsequently terminated due to Pandemic
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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).
The primary objectives of the study are to study the effectiveness of SP ganglion block in relieving post-dural puncture headache in terms of :
Secondary objectives are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sphenopalatine ganglion block | Experimental | Sphenopalatine ganglion block: this block will be performed by inserting swabs, with lidocaine squirted on them, into each nostril and reaching the nasopharyngeal wall. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Verghese Cherian, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subjects receiving a Sphenopalatine ganglion block for treatment of a severe post-epidural spinal headache. | Posted | Mean | Standard Deviation | units on a scale | 15 minutes before the SP block |
|
Subjects were monitored for any adverse events for 30 days post-SP block.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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The target enrollment was not reached secondary to the COVID-19 pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Verghese Cherian | Penn State Hershey Medical Center | 7175318521 | vcherian@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2021 | Apr 19, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 25, 2021 | Apr 19, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Open-label, single arm, pilot study
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|
| 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 |
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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Primary | 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. | Subjects receiving a Sphenopalatine ganglion block for treatment of a severe post-epidural spinal headache. | Posted | Mean | Standard Deviation | units on a scale | 60 minutes |
|
|
|
| Primary | 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. | Subjects receiving a Sphenopalatine ganglion block for treatment of a severe post-epidural spinal headache. | Posted | Mean | Standard Deviation | units on a scale | 1 day |
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|
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| Primary | 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. | Subjects receiving a Sphenopalatine ganglion block for treatment of a severe post-epidural spinal headache. | Posted | Mean | Standard Deviation | units on a scale | 2 days |
|
|
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| Primary | 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. | Subjects receiving a Sphenopalatine ganglion block for treatment of a severe post-epidural spinal headache. | Posted | Mean | Standard Deviation | units on a scale | 7 days |
|
|
|
| Primary | 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. | Subjects receiving a Sphenopalatine ganglion block for treatment of a severe post-epidural spinal headache. | Posted | Mean | Standard Deviation | units on a scale | 30 days |
|
|
|
| Secondary | 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. | Subjects who received an SP block for treatment of a severe post-epidural headache who did not see complete resolution of their pain. | Posted | Mean | Standard Deviation | hours | 24 hours |
|
|
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| Secondary | 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 | Subjects who received an SP block for treatment of a severe post-epidural headache who did not see complete resolution of their pain. | Posted | Count of Participants | Participants | 7 days |
|
|
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| Secondary | 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. | Subjects receiving a Sphenopalatine ganglion block for treatment of a severe post-epidural spinal headache. | Posted | Count of Participants | Participants | 15 minutes before the SP block to 30 days post SP block |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |