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.
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.
Stellate ganglion block with bupivacaine plus placebo (midazolam/saline) infusion.
Ultrasound/fluoroscopic SGB with ≈8 mL bupivacaine (local anaesthetic).
Placebo ketamine: midazolam 1–7 mg bolus and saline infusion over 30–60 min (described as placebo control).
Sham SGB (saline subcutaneous) plus ketamine infusion.
Sham SGB: 1–2 mL saline subcutaneously under imaging guidance.
Ketamine: bolus up to 0.3 mg/kg then total 0.5–1 mg/kg over 30–60 minutes; midazolam 1–4 mg given prior/with bolus as described.
Active SGB with bupivacaine plus active ketamine infusion (combination).
SGB with ≈8 mL bupivacaine under ultrasound/fluoroscopy.
Ketamine infusion: bolus up to 0.3 mg/kg then total 0.5–1 mg/kg over 30–60 min.
Sham SGB plus midazolam/saline placebo infusion.
Sham SGB: 1–2 mL saline subcutaneously.
Placebo ketamine: midazolam 1–7 mg bolus and saline infusion over 30–60 min.