Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04515901

Acronym

SPGB

Enrollment

Registered

2020-08-17

Start date

2021-12-01

Completion date

2022-11-11

Last updated

2022-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postdural Puncture Headache

Brief summary

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.

Interventions

DRUG2% lidocaine

Viscous lidocaine

OTHERPlacebo

Methylcellulose and cherry flavouring

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Enrollment rate	6 months	Number of consented patients over number of number of eligible patients

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026