A Phase 2 interventional study of Lidocaine in Post-Dural Puncture Headache and Sphenopalatine Ganglion Block, sponsored by Milton S. Hershey Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-15.
Sponsored by Milton S. Hershey Medical Center · Phase 2, Interventional, and Treatment
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:
Exclusion Criteria:
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
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.
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
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
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
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
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
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
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
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
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
| Milestone | Sphenopalatine Ganglion Block |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
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.
| units on a scale | Sphenopalatine Ganglion Block |
|---|---|
| Pain Score at Baseline | 9.33 ± 0.82 |
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.
| units on a scale | Sphenopalatine Ganglion Block |
|---|---|
| Pain Score 60 Minutes Post-SP Block | 0.33 ± 0.82 |
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.
| units on a scale | Sphenopalatine Ganglion Block |
|---|---|
| Pain Score 1 Day Post-SP Block | 5.33 ± 3.50 |
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.
| units on a scale | Sphenopalatine Ganglion Block |
|---|---|
| Pain Score 2 Days Post-SP Block | 3.67 ± 2.66 |
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.
| units on a scale | Sphenopalatine Ganglion Block |
|---|---|
| Pain Score 7 Days Post-SP Block | 2.33 ± 1.97 |
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.
| units on a scale | Sphenopalatine Ganglion Block |
|---|---|
| Pain Score 30 Day Post-SP Block | 1.67 ± 1.37 |
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.
| hours | Sphenopalatine Ganglion Block |
|---|---|
| Duration of Pain Relief | 13.50 ± 4.43 |
Patient reported recurrence of post dural puncture headache resulting in treatment with epidural blood patch
| Participants | Sphenopalatine Ganglion Block |
|---|---|
| Number of Participants With Recurrence of Post-dural Puncture Headache | 4 |
Patients will be asked to report any side effects, including: allergic reaction to lidocaine, nose irritation and nose-bleed.
| Participants | Sphenopalatine Ganglion Block |
|---|---|
| Number of Participants With Complications Due to SP Ganglion Block | 0 |
Collected over Subjects were monitored for any adverse events for 30 days post-SP block.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sphenopalatine Ganglion Block | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Sphenopalatine Ganglion Block |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Sphenopalatine Ganglion Block |
|---|---|
| Female | 5 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Sphenopalatine Ganglion Block |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Sphenopalatine Ganglion Block |
|---|---|
| United States | 6 |
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Milton S. Hershey Medical Center