Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 1
ConditionPost-Traumatic Headache
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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
Crossover
Treatments tested in this trial
Bupivacaine Injection
Drugsubcutaneous injection around bilateral greater occipital nerves
Treatment groups
12 Participants
are divided into 4 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Group D: Group 4Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute sensation felt during injection: quality
The quality of the sensation on the scalp at the time of injection (e.g., burning, shooting, aching)
Time frame
During injection2
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
Time frame
During injection3
Paresthesia felt after injection: quality
The quality of the sensation over the scalp after injection (e.g., numbing, tingling, coolness)
Time frame
From the time of injection to 1 week after injection4
Paresthesia felt after injection: intensity
The maximum intensity of the sensation over the scalp after injection on 0-10 numerical rating scale
Time frame
From the time of injection to 1 week after injectionSecondary outcomes
1
Adverse events
Complications that occur during or after injection
Time frame
From the first injection to two weeks after the last injectionSponsors 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