Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache
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|ClinicalTrials.gov Identifier: NCT03430531|
Recruitment Status : Suspended (Temporarily suspended due to Pandemic)
First Posted : February 13, 2018
Last Update Posted : April 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Post-Dural Puncture Headache Sphenopalatine Ganglion Block||Drug: Lidocaine||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label, single arm, pilot study|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache; A Pilot Study|
|Actual Study Start Date :||May 31, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Experimental: 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 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.
- Relief of pain [ Time Frame: 15 minutes before the SP block to 30 days post SP block ]Patient reported pain scores will be recorded at the following times and positions: Baseline (before SP block)-supine, baseline-sitting, during SP block, 5 min post SP block-supine, 5 min post SP block-sitting, 60 min post SP block-supine, 60 min post SP block-sitting, and for days 1, 2, 7, 30 days post SP block
- Time to onset of pain relief after application of block [ Time Frame: 15 minutes before the SP block to 30 days post SP block ]The time between the performance of the SP block and the time the patient reported pain score decreases from the baseline level.
- Duration of pain relief [ Time Frame: 15 minutes before the SP block to 30 days post SP block ]Patient reported pain scores, recorded at the times listed for Outcome 1, will be used to determine for how long after the SP block the patient reported pain scores that were decreased form the baseline measures (also describes for Outcome 1).
- Incidence of recurrence of post-dural puncture headache [ Time Frame: 15 minutes before the SP block to 30 days post SP block ]Patient reported recurrence of post dural puncture headache will be recorded.
- Complications due to SP ganglion block [ Time Frame: 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.
- Patient satisfaction with SP ganglion block [ Time Frame: 15 minutes before the SP block to 30 days post SP block ]Patients will report (yes/no) whether they are satisfied with the management of their headache.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430531
|United States, Pennsylvania|
|Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Verghese Cherian, MD||Milton S. Hershey Medical Center|