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NCT Number: NCT06069791

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location status: Recruiting

Location contact

Emmanuelle Schindler, MD, PhD

CONTACT

[email protected]

203-932-5711 ext. 4335

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Bupivacaine Injection

Drug

subcutaneous injection around bilateral greater occipital nerves

Primary outcomes

  1. Acute sensation felt during injection: quality

    Time frame: During injection

    The quality of the sensation on the scalp at the time of injection (e.g., burning, shooting, aching)

  2. Acute sensation felt during injection: intensity

    Time frame: During injection

    The maximum intensity of the sensation on the scalp at the time of injection on 0-10 numerical rating scale

  3. Paresthesia felt after injection: quality

    Time frame: From the time of injection to 1 week after injection

    The quality of the sensation over the scalp after injection (e.g., numbing, tingling, coolness)

  4. Paresthesia felt after injection: intensity

    Time frame: From the time of injection to 1 week after injection

    The maximum intensity of the sensation over the scalp after injection on 0-10 numerical rating scale

  5. Paresthesia felt after injection: distribution

    Time frame: From the time of injection to 1 week after injection

    The location of the sensation over the scalp after injection, drawn on figure of head and neck

  6. Paresthesia felt after injection: duration

    Time frame: From the time of injection to 1 week after injection

    The duration of the sensation over the scalp after injection (hours)

Secondary outcomes

  1. Adverse events

    Time frame: From the first injection to two weeks after the last injection

    Complications that occur during or after injection

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuelle Schindler, MD, PhD

CONTACT

[email protected]

203-932-5711 ext. 4335

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Headache Foundation
  • VA Connecticut Healthcare System

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2023
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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