Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 1

NCT ID: NCT06069791

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-26
• Study Completion Date: 2026-12-31

Brief Summary

The acute and subacute sensations that occur on the scalp with injection of different concentrations of bupivacaine for grater occipital nerve blockade will be compared. Each Veteran participant will be randomized to receive three different concentrations, which will be injected one week apart each.

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.

The acute burning that occurs during injection and then the numbing over the scalp that occurs shortly after anesthetic GON blockade make controlled investigations against placebo difficult to interpret. In sub-study 1 of this project, different concentrations of bupivacaine (0.0%, 0.01%, 0.05%, 0.1%) will be examined in order to identify a suitable control dose to later compare to the full dose of 0.5%. Acute and subacute sensations from bupivacaine GON blockade will be measured and the lowest concentration that resembles the sensations elicited by full dose (0.5%) will be used in a subsequent efficacy trial (sub-study 2).

Conditions

Post-Traumatic Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Group 2

bupivacaine 0.1%, 0.05%, and 0.1% in random order, one week apart each

Group Type: EXPERIMENTAL

Bupivacaine Injection

Intervention Type: DRUG

subcutaneous injection around bilateral greater occipital nerves

Group 3

bupivacaine 0.0%, 0.1%, and 0.5% in random order, one week apart each

Group Type: EXPERIMENTAL

Bupivacaine Injection

Intervention Type: DRUG

subcutaneous injection around bilateral greater occipital nerves

Group 4

bupivacaine \[0.01% or 0.05%\], \[0.05% or 0.1%\], and 0.05% in random order, one week apart each

Group Type: EXPERIMENTAL

Bupivacaine Injection

Intervention Type: DRUG

subcutaneous injection around bilateral greater occipital nerves

Group 1

bupivacaine 0.0%, 0.01%, and 0.05% in random order, one week apart each

Group Type: EXPERIMENTAL

Bupivacaine Injection

Intervention Type: DRUG

subcutaneous injection around bilateral greater occipital nerves

Interventions

Bupivacaine Injection

subcutaneous injection around bilateral greater occipital nerves

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• United States Military Veterans within VA Connecticut Healthcare System
• Chronic post-traumatic headache per ICHD-3 criteria (i.e., headaches are continuing to occur three months after the head injury)
• At least two headache days per week
• MRI brain scan completed within the past 3 months if chronic PTH for less than one year, within the past year if chronic PTH for less than 5 years, and within 5 years if chronic PTH for more than 10 years
• Review of MRI and the medical record does not reveal another source for headache

Exclusion Criteria

• Skull defect
• Other contraindication to bupivacaine

1. Allergy or adverse reaction (e.g., rash, cardiac effects) to amide anesthetics, such as lidocaine

2. Instruction from clinician to avoid amide anesthetics, such as lidocaine

• Pregnant or lack of adequate birth control

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Connecticut Healthcare System

FED

Sponsor Role: collaborator

National Headache Foundation

UNKNOWN

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

VA Connecticut Healthcare System

West Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Emmanuelle Schindler, MD, PhD

Role: CONTACT

emmanuelle.schindler@va.gov

203-932-5711 ext. 4335

Facility Contacts

Emmanuelle Schindler, MD, PhD

Role: primary

emmanuelle.schindler@va.gov

203-932-5711 ext. 4335

Other Identifiers

1656679

Identifier Type: -

Identifier Source: org_study_id