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Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches

NCT04515901 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-12-16

No results posted yet for this study

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

Interventions

DRUG

2% lidocaine

Viscous lidocaine

OTHER

Placebo

Methylcellulose and cherry flavouring

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-11-11
Completion
2022-11-11

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04515901 on ClinicalTrials.gov