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

Post-Traumatic Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06069791
• Other study ID #: 1656679
• Status: Recruiting
• Phase: Phase 1
• Start date: January 26, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: Emmanuelle Schindler, MD, PhD
• Phone: 203-932-5711
• Email: emmanuelle.schindler[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-Traumatic Headache

Intervention

Drug:
• Bupivacaine Injection
subcutaneous injection around bilateral greater occipital nerves

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Headache Foundation, VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Adverse events	Complications that occur during or after injection	From the first injection to two weeks after the last injection