NCT07796074

Brief Summary

Anesthetic greater occipital nerve (GON) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects. In this study, Veterans with post-traumatic headache will be randomized to receive 0.0%, 0.05%, or 0.5% bupivacaine in bilateral GON blocks and the lasting (i.e., transitional) effects on headache frequency measured in a headache diary.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
15mo left

Started Sep 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress7%
Sep 2026Dec 2027

First Submitted

Initial submission to the registry

August 21, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

1.1 years

First QC Date

August 21, 2026

Last Update Submit

September 2, 2026

Conditions

Post-Traumatic Headache

Outcome Measures

Primary Outcomes (1)

  • Change in headache days/week in the first month

    Change in the weekly number of headache days after GON blockade

    From one month before to one month after injection

Secondary Outcomes (12)

  • Change in headache days/week over two months

    From one month before to two months after injection

  • Change in average headache pain intensity

    From one month before to two months after injection

  • Change in average attack duration

    From one month before to two months after injection

  • Change in average headache-associated light sensitivity

    From one month before to two months after injection

  • Change in average headache-associated sound sensitivity

    From one month before to two months after injection

  • +7 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

0.0% bupivacaine (normal saline)

Drug: Bupivacaine bilateral greater occipital nerve block

Low dose bupivacaine

ACTIVE COMPARATOR

0.05% bupivacaine

Drug: Bupivacaine bilateral greater occipital nerve block

Full dose bupivacaine

EXPERIMENTAL

0.5% bupivacaine

Drug: Bupivacaine bilateral greater occipital nerve block

Interventions

Bupivacaine bilateral greater occipital nerve blockDRUG

Three subcutaneous injections of 1 mL each will be injected on both sides of the occipital region around the greater occipital nerve.

Full dose bupivacaineLow dose bupivacainePlacebo

Eligibility Criteria

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

You may qualify if:

  • United States Military Veterans within VA Connecticut Healthcare System1.
  • Head injury with headaches that have continued to occur for at least three months after the head injury
  • At least two headache days per week
  • Review of the medical record does not reveal another source for headache

You may not qualify if:

  • Skull defect
  • Other contraindication to bupivacaine
  • Allergy or adverse reaction (e.g., rash, cardiac effects) to amide anesthetics, such as lidocaine
  • Instruction from clinician to avoid amide anesthetics, such as lidocaine
  • Pregnant or lack of adequate birth control
  • Clinical review of the patient's case reveals red flag signs or symptoms (e.g., side-locked pain, unilateral numbness/weakness during headache, rapid ascension to peak pain, syncope during attacks) that warrant further work-up (e.g., MRI, arterial imaging).
  • Absence of imaging warranted by the standard of clinical care for the head injury with headaches.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

RECRUITING

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Emmanuelle Schindler, MD, PhD

    VA Connecticut Healthcare System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuelle Schindler, MD, PhD

CONTACT

203-932-5711emmanuelle.schindler@va.gov

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2026

First Posted

August 31, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

September 8, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Data collected in this study include patient information that must remain behind the US Veterans Affairs firewall.

Locations

US(1)