Recruiting
Phase 2

GON Blockade

Sponsor:

Yale University

Code:

NCT07796074

Conditions

Post-Traumatic Headache

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine bilateral greater occipital nerve block

Study Details

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.

Conditions

Post-Traumatic Headache

Study ID

NCT07796074

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

0.0% bupivacaine (normal saline)

active comparator: Low dose bupivacaine

0.05% bupivacaine

experimental: Full dose bupivacaine

0.5% bupivacaine

Interventions

Bupivacaine bilateral greater occipital nerve block

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

Primary outcome measure

  • Change in headache days/week in the first month [ Time Frame: From one month before to one month after injection ]

Central Contacts and Locations

Central contacts

Emmanuelle Schindler, MD, PhD

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

Locations

VA Connecticut Healthcare System

Recruiting

West Haven, Connecticut, United States, 06516

Contacts

Emmanuelle Schindler, MD, PhD

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

More Information

Sponsor

Yale University

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-09-08.