Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

Post-Dural Puncture Headache Clinical Trial

Official title:

Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache; A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03430531
• Other study ID #: 8426
• Status: Terminated
• Phase: Phase 2
• Start date: May 31, 2019
• Est. completion date: March 11, 2022

Study information

• Verified date: May 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 11, 2022
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ganglion Cysts
• Headache
• Post-Dural Puncture Headache
• Sphenopalatine Ganglion Block

Intervention

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.

Locations

Country	Name	City	State
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	15 minutes before the SP block
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.	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.	1 day
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.	2 days
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.	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.	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.	24 hours
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	7 days
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.	15 minutes before the SP block to 30 days post SP block