Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches

NCT04515901 | Withdrawn

• 1 other identifier: 7978
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Postdural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• Enrollment rate

  Number of consented patients over number of number of eligible patients

  6 months

Study Arms (2)

SPGB

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

It will be adminstered the same as the experimental arm but with methylcellulose and cherry flavouring to match odour and taste.

Other: Placebo

Interventions

2% lidocaine DRUG

Viscous lidocaine

SPGB

Placebo OTHER

Methylcellulose and cherry flavouring

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45
• Confirmed PDPH as per ICHD-3 diagnostic criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University Medical Centre

Hamilton, Ontario, L8S 4K1, Canada

Location

Related 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.

  PMID: 15814755 BACKGROUND

• 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.

  PMID: 7085264 BACKGROUND

• 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.

  PMID: 28757848 BACKGROUND

• 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.

  PMID: 12734154 BACKGROUND

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 17, 2020
• Study Start: December 1, 2021
• Primary Completion: November 11, 2022
• Study Completion: November 11, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)