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

Anesthetic Greater Occipital Nerve Blockade in Veterans With Post-Traumatic 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.

Study Overview

• Status: Recruiting
• Conditions: Post-Traumatic Headache
• Intervention / Treatment: Drug: Bupivacaine Injection

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).

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Emmanuelle Schindler, MD, PhD; Phone Number: 4335 203-932-5711; Email: emmanuelle.schindler@va.gov

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • Recruiting
      • VA Connecticut Healthcare System
      • Contact: Emmanuelle Schindler, MD, PhD; Phone Number: 4335 203-932-5711; Email: emmanuelle.schindler@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; bupivacaine 0.0%, 0.01%, and 0.05% in random order, one week apart each	Drug: Bupivacaine Injection; subcutaneous injection around bilateral greater occipital nerves
Experimental: Group 2; bupivacaine 0.1%, 0.05%, and 0.1% in random order, one week apart each	Drug: Bupivacaine Injection; subcutaneous injection around bilateral greater occipital nerves
Experimental: Group 3; bupivacaine 0.0%, 0.1%, and 0.5% in random order, one week apart each	Drug: Bupivacaine Injection; subcutaneous injection around bilateral greater occipital nerves
Experimental: Group 4; bupivacaine [0.01% or 0.05%], [0.05% or 0.1%], and 0.05% in random order, one week apart each	Drug: Bupivacaine Injection; subcutaneous injection around bilateral greater occipital nerves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute sensation felt during injection: quality	The quality of the sensation on the scalp at the time of injection (e.g., burning, shooting, aching)	During injection
Acute sensation felt during injection: intensity	The maximum intensity of the sensation on the scalp at the time of injection on 0-10 numerical rating scale	During injection
Paresthesia felt after injection: quality	The quality of the sensation over the scalp after injection (e.g., numbing, tingling, coolness)	From the time of injection to 1 week after injection
Paresthesia felt after injection: intensity	The maximum intensity of the sensation over the scalp after injection on 0-10 numerical rating scale	From the time of injection to 1 week after injection
Paresthesia felt after injection: distribution	The location of the sensation over the scalp after injection, drawn on figure of head and neck	From the time of injection to 1 week after injection
Paresthesia felt after injection: duration	The duration of the sensation over the scalp after injection (hours)	From the time of injection to 1 week after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Complications that occur during or after injection	From the first injection to two weeks after the last injection

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: VA Connecticut Healthcare System; National Headache Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: veteran; traumatic brain injury; VA Connecticut Healthcare System
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Traumatic Headache; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 1656679

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No