A Phase 2 interventional study of Bupivacaine bilateral greater occipital nerve block in Post-Traumatic Headache, sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Yale University · Phase 2, Interventional, and Treatment
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.
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.
In this second portion of this study, Veterans with chronic post-traumatic headache will be randomized to receive 0.0%, 0.05%, or 0.5% bupivacaine in bilateral GON blocks. They will maintain a headache diary to measure the change in headache frequency over the two months after injection. This design uses information gathered from sub-study 1 of this project (NCT#06069791). In that initial intervention, different concentrations of bupivacaine were examined to consider the intensity and spread of acute and subacute sensations that occur with GON blockade. This allowed us to select a low dose (0.05%) that approximates the sensations of the full dose of 0.5%.
192 studies on the registry are indexed under Post-Traumatic Headache; 54 are open to participants now.
This study's planned enrollment of 36 is below the median of 44 across 169 interventional studies indexed under Post-Traumatic Headache.
Browse Post-Traumatic Headache studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.0% bupivacaine (normal saline)
Drug: Bupivacaine bilateral greater occipital nerve block
0.05% bupivacaine
Drug: Bupivacaine bilateral greater occipital nerve block
0.5% bupivacaine
Drug: Bupivacaine bilateral greater occipital nerve block
Three subcutaneous injections of 1 mL each will be injected on both sides of the occipital region around the greater occipital nerve.
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
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
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
Change in average attack duration
Hours
Time frame: From one month before to two months after injection
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
Change in average headache-associated sound 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
Change in average headache-associated nausea/vomiting
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
Change in average headache-associated functional impairment
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
Change in average days/week using headache abortive treatment
Number of days per week using an abortive treatment for headache
Time frame: From one month before to two months after injection
Patient Global Impression of Change scale (PGIC)
Scale of 1-7 with higher scores indicating worse outcome.
Time frame: From one month before to two months after injection
Migraine-Specific Quality of Life questionnaire (v2.1) (MSQ)
0-to-100 scale. Higher scores indicate better quality of life.
Time frame: From one month before to two months after injection
Migraine Disability Assessment (MIDAS)
Score from 0 to 270. Higher scores indicating more severe disability.
Time frame: From one month before to two months after injection
Number of participants with Adverse events
Number of participants with Adverse events that occur during or after injection
Time frame: From one month before to two months after injection
Plan to share: No — Data collected in this study include patient information that must remain behind the US Veterans Affairs firewall.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
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