NCT07796074PHASE2Recruiting

Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 2

Yale University

Start Date

9/1/2026

Completion Date

12/31/2027

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.

Detailed Description

Military Servicemembers are at elevated risk for traumatic brain injury (TBI) and its consequences, including post-traumatic headache (PTH). The most common phenotype of PTH is migraine, for which there are numerous potential treatments, though these have limitations, including poor efficacy, drug-drug interactions, and intolerable side effects. Therefore, the consideration of other methods to manage PTH in Servicemembers and Veterans is warranted. Anesthetic greater occipital nerve (GON) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects in a variety of headache disorders. This intervention is frequently done to provide immediate relief, followed by a period of reduced headache burden. In this second portion of this study, Veterans with chronic post-traumatic headache will be randomized to receive 0.0%, 0.05%, or 0.5% bupivacaine in bilateral GON blocks. They will maintain a headache diary to measure the change in headache frequency over the two months after injection. This design uses information gathered from sub-study 1 of this project (NCT#06069791). In that initial intervention, different concentrations of bupivacaine were examined to consider the intensity and spread of acute and subacute sensations that occur with GON blockade. This allowed us to select a low dose (0.05%) that approximates the sensations of the full dose of 0.5%.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Bupivacaine bilateral greater occipital nerve block

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Conditions

Post-Traumatic Headache

Locations

VA Connecticut Healthcare System

West Haven, Connecticut 06516

United States