Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches

Study Overview
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Brief Summary
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Postdural puncture headache (PDPH) is a severe, debilitating complication of dural puncture that can arise from insertion of an epidural or spinal needle for labour analgesia. Presently, the conservative treatment options for PDPH have limited effectiveness and the gold standard treatment for PDPH, an epidural blood patch, is an invasive intervention with the potential for serious complications. There is a growing number of case reports and retrospective studies that suggest a sphenopalatine ganglion block (SPGB) with local anesthetic may offer an effective, safe, and easy-to-administer treatment option for PDPH in postpartum patients. We aim to conduct a feasibility study to assess whether a randomized controlled trial is feasible comparing whether early intervention SPGB with the option for repeat, patient self-administered SPGBs versus current standard conservative management can reduce the severity and duration of PDPH pain and improve patient functional status.

Official Title
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Early Intervention Sphenopalatine Ganglion Blocks (SPGBs) Versus Standard Conservative Management of Post Dural Puncture Headache in Obstetric Patients - A Randomized Feasibility Study

Conditions
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Postdural Puncture Headache

Intervention / Treatment
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* Drug: 2% lidocaine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-45 Confirmed PDPH as per ICHD-3 diagnostic criteria Exclusion Criteria: American Society of Anesthesiologists (ASA) class 4 and above History of chronic headaches or migraines requiring prescription medication Known nasal septal deformity or abnormality Known allergy to amide anesthetics Intrathecal catheters Patients who received EBP on the initial presentation with PDPH who declined a trial of conservative management Postpartum complication delaying maternal discharge

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPGB<br>Via a soft tip 20-gauge long IV catheter attached to a 3 mL syringe will be filled with 2 mL of 2% viscous lidocaine. The 2% viscous lidocaine will be administered according to the method of Barre. | Drug: 2% lidocaine<br>* Viscous lidocaine<br>|
| Placebo Comparator: Placebo<br>It will be adminstered the same as the experimental arm but with methylcellulose and cherry flavouring to match odour and taste. | Other: Placebo<br>* Methylcellulose and cherry flavouring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment rate | Number of consented patients over number of number of eligible patients | 6 months |