Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches

Postdural Puncture Headache Clinical Trial

— SPGB  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04515901
• Other study ID #: 7978
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: November 11, 2022

Study information

• Verified date: December 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 11, 2022
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Postdural Puncture Headache

Intervention

Drug:
• 2% lidocaine
Viscous lidocaine

Other:
• Placebo
Methylcellulose and cherry flavouring

Locations

Country	Name	City	State
Canada	McMaster University Medical Centre	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Angle P, Tang SL, Thompson D, Szalai JP. Expectant management of postdural puncture headache increases hospital length of stay and emergency room visits. Can J Anaesth. 2005 Apr;52(4):397-402. doi: 10.1007/BF03016283. — View Citation

Barre F. Cocaine as an abortive agent in cluster headache. Headache. 1982 Mar;22(2):69-73. doi: 10.1111/j.1526-4610.1982.hed2202069.x. No abstract available. — View Citation

Channabasappa SM, Manjunath S, Bommalingappa B, Ramachandra S, Banuprakash S. Transnasal sphenopalatine ganglion block for the treatment of postdural puncture headache following spinal anesthesia. Saudi J Anaesth. 2017 Jul-Sep;11(3):362-363. doi: 10.4103/sja.SJA_59_17. No abstract available. — View Citation

Choi PT, Galinski SE, Takeuchi L, Lucas S, Tamayo C, Jadad AR. PDPH is a common complication of neuraxial blockade in parturients: a meta-analysis of obstetrical studies. Can J Anaesth. 2003 May;50(5):460-9. doi: 10.1007/BF03021057. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment rate	Number of consented patients over number of number of eligible patients	6 months