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Stellate Ganglion Block for PTSD
NCT05391971Phase 4
Key facts
- Status
- Active, not recruiting
- Start
- Aug 2022
- Primary completion
- Jun 2026
- Countries
- 1
- Sponsor
- NYU Langone Health
- Modality
- Small Molecules
- Drugs
- bupivacaine
- Conditions
- post-traumatic stress disorder (PTSD)
01
Overview
Phase 4, randomised, double-blind trial of bupivacaine in post-traumatic stress disorder (PTSD) (2 arms), sponsored by NYU Langone Health. Primary endpoints: Change in Skin Conductance Response Amount at Week 8 and Change in Cerebral Blood Flow Levels at Week 8. Started Aug 2022; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Stellate Ganglion Block (SGB) Group
Participants receive bupivacaine injection.
Control Group
Participants receive saline injection.
03
Who it enrols
Adults aged 18-65 with chronic DSM-5 PTSD symptoms, stable on medications, excluding those with prior stellate ganglion block, severe psychiatric or substance use disorders, significant suicidal risk, or contraindications to MRI or local anesthetics.
04
Endpoints
Primary
Change in Skin Conductance Response Amount
Change in Cerebral Blood Flow Levels
Secondary
Posttraumatic Stress Disorder Checklist
Patient Health Questionnaire-9
State-Trait Anxiety Inventory - Form Y1
Intolerance of Uncertainty Scale - Short Form
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