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

NCT06069791 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 1656679
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Traumatic Headache

Keywords

traumatic brain injury; veteran; VA Connecticut Healthcare System

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Adverse events

  From the first injection to two weeks after the last injection

Study Arms (4)

Group 1

EXPERIMENTAL

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

Drug: Bupivacaine Injection

Group 2

EXPERIMENTAL

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

Drug: Bupivacaine Injection

Group 3

EXPERIMENTAL

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

Drug: Bupivacaine Injection

Group 4

EXPERIMENTAL

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

Drug: Bupivacaine Injection

Interventions

Bupivacaine Injection DRUG

subcutaneous injection around bilateral greater occipital nerves

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Headache Foundation: collaborator
• Yale University: lead
• VA Connecticut Healthcare System: collaborator

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

RECRUITING

MeSH Terms

Conditions

Post-Traumatic Headache; Brain Injuries, Traumatic

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Emmanuelle Schindler, MD, PhD

CONTACT

203-932-5711; emmanuelle.schindler@va.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both bupivacaine concentration and order of administration will be unknown except to Research Pharmacy
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: incomplete block assignment

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 6, 2023
• Study Start: January 26, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)