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

Phase 1

Recruiting

• Conditions: Post-Traumatic Headache
• Interventions: Drug: Bupivacaine Injection

• Registration Number: NCT06069791
• Lead Sponsor: Yale University

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).

Study Timeline

• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-06
• Study Start: 2024-01-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Bupivacaine Injection	bupivacaine 0.0%, 0.01%, and 0.05% in random order, one week apart each
Group 2	Bupivacaine Injection	bupivacaine 0.1%, 0.05%, and 0.1% in random order, one week apart each
Group 3	Bupivacaine Injection	bupivacaine 0.0%, 0.1%, and 0.5% in random order, one week apart each
Group 4	Bupivacaine Injection	bupivacaine \[0.01% or 0.05%\], \[0.05% or 0.1%\], and 0.05% in random order, one week apart each

Primary Outcome Measures

Name	Time	Method
Acute sensation felt during injection: quality	During injection	The quality of the sensation on the scalp at the time of injection (e.g., burning, shooting, aching)
Acute sensation felt during injection: intensity	During injection	The maximum intensity of the sensation on the scalp at the time of injection on 0-10 numerical rating scale
Paresthesia felt after injection: distribution	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
Paresthesia felt after injection: duration	From the time of injection to 1 week after injection	The duration of the sensation over the scalp after injection (hours)
Paresthesia felt after injection: quality	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)
Paresthesia felt after injection: intensity	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

Secondary Outcome Measures

Name	Time	Method
Adverse events	From the first injection to two weeks after the last injection	Complications that occur during or after injection

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States