Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches

Not Applicable

Withdrawn

• Conditions: Postdural Puncture Headache
• Interventions: Drug: 2% lidocaine; Other: Placebo

• Registration Number: NCT04515901
• Lead Sponsor: McMaster University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-17
• Study Start: 2021-12-01
• Primary Completion: 2022-11-11
• Study Completion: 2022-11-11
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPGB	2% lidocaine	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.
Placebo	Placebo	It will be adminstered the same as the experimental arm but with methylcellulose and cherry flavouring to match odour and taste.

Primary Outcome Measures

Name	Time	Method
Enrollment rate	6 months	Number of consented patients over number of number of eligible patients

Trial Locations

Locations (1)

McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada