Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache; A Pilot Study
Overview
- Phase
- Phase 2
- Intervention
- Lidocaine
- Conditions
- Post-Dural Puncture Headache
- Sponsor
- Milton S. Hershey Medical Center
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Pain Score at Baseline
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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
Investigators
Verghese T Cherian, MD
Associate Professor of Anesthesiology & Perioperative Medicine
Milton S. Hershey Medical Center
Eligibility Criteria
Inclusion Criteria
- •Complains of symptoms suggestive of post-dural puncture headache
- •Has a history of dural puncture (lumbar puncture or accidental dural puncture during epidural placement) within the previous 7 days
- •Fluent in written and spoken English
Exclusion Criteria
- •Those with a known history of hypersensitivity to local anesthetics of the amide type or to other components of GLYDO
- •Those with any congenital or acquired, anatomical deformity of the nostril, which preclude performing the block
- •Those who refuse to consent to participate in the study
- •Patients who have had a failed epidural blood patch
- •Cognitive Impairment
Arms & Interventions
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.
Intervention: Lidocaine
Outcomes
Primary Outcomes
Pain Score at Baseline
Time Frame: 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
Time Frame: 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
Time Frame: 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 2 Days Post-SP Block
Time Frame: 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.
Pain Score 7 Days Post-SP Block
Time Frame: 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 30 Day Post-SP Block
Time Frame: 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.
Secondary Outcomes
- Duration of Pain Relief(24 hours)
- Number of Participants With Recurrence of Post-dural Puncture Headache(7 days)
- Number of Participants With Complications Due to SP Ganglion Block(15 minutes before the SP block to 30 days post SP block)