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Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches (SPGB)

Primary Purpose

Postdural Puncture Headache

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
2% lidocaine
Placebo
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postdural Puncture Headache

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • McMaster University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SPGB

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Enrollment rate
Number of consented patients over number of number of eligible patients

Secondary Outcome Measures

Full Information

First Posted
August 11, 2020
Last Updated
December 14, 2022
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT04515901
Brief Title
Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to enroll participants.
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
November 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postdural Puncture Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPGB
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
It will be adminstered the same as the experimental arm but with methylcellulose and cherry flavouring to match odour and taste.
Intervention Type
Drug
Intervention Name(s)
2% lidocaine
Intervention Description
Viscous lidocaine
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Methylcellulose and cherry flavouring
Primary Outcome Measure Information:
Title
Enrollment rate
Description
Number of consented patients over number of number of eligible patients
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15814755
Citation
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.
Results Reference
background
PubMed Identifier
7085264
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.
Results Reference
background
PubMed Identifier
28757848
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.
Results Reference
background
PubMed Identifier
12734154
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.
Results Reference
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Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches

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