Health TrialsbyHealthPanel

Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 2

ConditionPost-Traumatic Headache
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

Anesthetic greater occipital nerve (GON) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects. In this study, Veterans with post-traumatic headache will be randomized to receive 0.0%, 0.05%, or 0.5% bupivacaine in bilateral GON blocks and the lasting (i.e., transitional) effects on headache frequency measured in a headache diary.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

United States Military Veterans within VA Connecticut Healthcare System1.

Head injury with headaches that have continued to occur for at least three months after the head injury

At least two headache days per week

Review of the medical record does not reveal another source for headache

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivacaine bilateral greater occipital nerve block

    Drug

    Three subcutaneous injections of 1 mL each will be injected on both sides of the occipital region around the greater occipital nerve.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Low dose bupivacaineActive comparator 1 intervention
Group C: Full dose bupivacaineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in headache days/week in the first month

Change in the weekly number of headache days after GON blockade

Time frame
From one month before to one month after injection

Secondary outcomes

1

Change in headache days/week over two months

Change in number of days per week with headache

Time frame
From one month before to two months after injection
2

Change in average headache pain intensity

Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)

Time frame
From one month before to two months after injection
3

Change in average attack duration

Hours

Time frame
From one month before to two months after injection
4

Change in average headache-associated light sensitivity

Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)

Time frame
From one month before to two months after injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

VA Connecticut Healthcare System

Collaborator

National Headache Foundation

Collaborator

Source ClinicalTrials.gov
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