Ketamine, SGB and Combination Treatment for TBI
This randomised, double-blind, placebo-controlled trial (n=175) will investigate the efficacy of stellate ganglion block (SGB) and ketamine infusion, both separately and in combination, in treating PTSD and TBI-associated headache.
Details
Multicentre, randomized, double-blind, placebo-controlled parallel trial assigning 175 participants in a 2:2:2:1 ratio to SGB, sham SGB, ketamine infusion, placebo infusion, or combination SGB plus ketamine to assess effects on TBI-related headache and PTSD.
Primary outcomes assessed at 4 weeks with additional visits at 1, 2, 8 and 12 weeks and observational follow-up to 6 and 12 months for responders; exploratory imaging and biomarker aims included at select sites.
Interventions: single ultrasound/fluoroscopic SGB with ≈8 mL bupivacaine and IV ketamine infusion (bolus up to 0.3 mg/kg, total 0.5–1 mg/kg over 30–60 minutes); placebo conditions use midazolam and saline as described in protocol.