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Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches

NCT ID: NCT04515901

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-11-11

Brief Summary

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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

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Conditions

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Postdural Puncture Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SPGB

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.

Group Type EXPERIMENTAL

2% lidocaine

Intervention Type DRUG

Viscous lidocaine

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Methylcellulose and cherry flavouring

Interventions

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2% lidocaine

Viscous lidocaine

Intervention Type DRUG

Placebo

Methylcellulose and cherry flavouring

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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McMaster University Medical Centre

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 15814755 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7085264 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28757848 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12734154 (View on PubMed)

Other Identifiers

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7978

Identifier Type: -

Identifier Source: org_study_id