Post-Dural Puncture Headache, Sphenopalatine Ganglion Block
Conditions
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
Interventions
DRUGLidocaine
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.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, single arm, pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 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 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Sphenopalatine Ganglion Block |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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.
Time frame: 1 day
Population: Subjects receiving a Sphenopalatine ganglion block for treatment of a severe post-epidural spinal headache.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sphenopalatine Ganglion Block | Pain Score 1 Day Post-SP Block | 5.33 units on a scale | Standard Deviation 3.5 |
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.
Time frame: 2 days
Population: Subjects receiving a Sphenopalatine ganglion block for treatment of a severe post-epidural spinal headache.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sphenopalatine Ganglion Block | Pain Score 2 Days Post-SP Block | 3.67 units on a scale | Standard Deviation 2.66 |
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.
Time frame: 30 days
Population: Subjects receiving a Sphenopalatine ganglion block for treatment of a severe post-epidural spinal headache.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sphenopalatine Ganglion Block | Pain Score 30 Day Post-SP Block | 1.67 units on a scale | Standard Deviation 1.37 |
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.
Time frame: 60 minutes
Population: Subjects receiving a Sphenopalatine ganglion block for treatment of a severe post-epidural spinal headache.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sphenopalatine Ganglion Block | Pain Score 60 Minutes Post-SP Block | 0.33 units on a scale | Standard Deviation 0.82 |
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.
Time frame: 7 days
Population: Subjects receiving a Sphenopalatine ganglion block for treatment of a severe post-epidural spinal headache.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sphenopalatine Ganglion Block | Pain Score 7 Days Post-SP Block | 2.33 units on a scale | Standard Deviation 1.97 |
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.
Time frame: 15 minutes before the SP block
Population: Subjects receiving a Sphenopalatine ganglion block for treatment of a severe post-epidural spinal headache.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sphenopalatine Ganglion Block | Pain Score at Baseline | 9.33 units on a scale | Standard Deviation 0.82 |
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.
Time frame: 24 hours
Population: Subjects who received an SP block for treatment of a severe post-epidural headache who did not see complete resolution of their pain.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sphenopalatine Ganglion Block | Duration of Pain Relief | 13.50 hours | Standard Deviation 4.43 |
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.
Time frame: 15 minutes before the SP block to 30 days post SP block
Population: Subjects receiving a Sphenopalatine ganglion block for treatment of a severe post-epidural spinal headache.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sphenopalatine Ganglion Block | Number of Participants With Complications Due to SP Ganglion Block | 0 Participants |
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
Time frame: 7 days
Population: Subjects who received an SP block for treatment of a severe post-epidural headache who did not see complete resolution of their pain.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sphenopalatine Ganglion Block | Number of Participants With Recurrence of Post-dural Puncture Headache | 4 Participants |