NCT06997562

Brief Summary

This study compares the effectiveness of greater occipital nerve blockade and sphenopalatine ganglion blockade in reducing headache intensity, duration, frequency, and disability in patients with episodic migraine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

May 21, 2025

Last Update Submit

May 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Degree of headache intensity

    Reduction in headache intensity will be recorded using numeric rating scale (NRS). Each patient will be instructed about pain assessment with NRS score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").

    3 months post-procedure

Secondary Outcomes (3)

  • Migraine disability assessment score

    3 months post-procedure

  • Headache duration

    3 months post-procedure

  • Headache frequency

    3 months post-procedure

Study Arms (2)

Greater occipital nerve blockade group

EXPERIMENTAL

Patients will receive greater occipital nerve blockade using 2 mL of 2% lidocaine at the medial one-third of the line between the occipital protuberance and mastoid process.

Other: Greater occipital nerve blockade

Sphenopalatine ganglion blockade group

EXPERIMENTAL

Patients will receive greater sphenopalatine ganglion blockade using 2 mL of 2% lidocaine using a transnasal approach with a cotton swab inserted along the superior middle turbinate to the posterior nasopharyngeal wall.

Other: Sphenopalatine ganglion blockade

Interventions

Patients will receive greater occipital nerve blockade using 2 mL of 2% lidocaine at the medial one-third of the line between the occipital protuberance and mastoid process.

Greater occipital nerve blockade group

Patients will receive greater sphenopalatine ganglion blockade using 2 mL of 2% lidocaine using a transnasal approach with a cotton swab inserted along the superior middle turbinate to the posterior nasopharyngeal wall.

Sphenopalatine ganglion blockade group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-65 years.
  • Both sexes.
  • Diagnosed with episodic migraine per the International Classification of Headache Disorders, 3rd edition (ICHD-3).
  • Failure to achieve adequate relief with at least one prophylactic migraine treatment.

You may not qualify if:

  • Chronic migraine (≥15 headache days per month).
  • History of nerve blocks within the last 6 months.
  • Known allergy to anesthetic agents.
  • Pregnancy or lactation.
  • Active psychiatric conditions affecting compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Valley University

New Valley, New Valley Governorate, 72511, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia and Intensive Care, Faculty of Medicine, New Valley University, Egypt.

Study Record Dates

First Submitted

May 21, 2025

First Posted

May 30, 2025

Study Start

May 1, 2024

Primary Completion

May 3, 2025

Study Completion

May 3, 2025

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations