Stellate Ganglion Block to Augment Trauma-focused Therapy Among Veterans With PTSD

PHASE2CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

January 3, 2022

Primary Completion Date

March 31, 2025

Study Completion Date

March 31, 2025

Conditions
PTSDTrauma and Stressor Related DisordersTrauma, PsychologicalPost Traumatic Stress Disorder
Interventions
BEHAVIORAL

Cognitive Processing Therapy (CPT)

Cognitive processing therapy (CPT) is a specific type of cognitive behavioral therapy that has been effective in reducing symptoms of PTSD that have developed after experiencing a variety of traumatic events including child abuse, combat, rape and natural disasters. CPT is generally delivered over 12 sessions and helps patients learn how to challenge and modify unhelpful beliefs related to the trauma. In so doing, the patient creates a new understanding and conceptualization of the traumatic event so that it reduces its ongoing negative effects on current life. This treatment is strongly recommended for the treatment of PTSD.

DRUG

Stellate Ganglion Block

SGB is a procedure that has demonstrated efficacy for the reduction of PTSD symptoms. SGB is performed using real-time ultrasonography with an in-plane technique, and consists of 7-10 mL of ropivacaine 0.5%, which is injected around and into the site of the ganglion at the level of the C4 and C6 anterior tubercle (Mulvaney, Curtis et al., 2020). Ropivacaine is a long-acting amide local anesthetic agent and a pure S-enantiomer with a high pKa and relatively low solubility. Patients are not sedated during the procedure. Successful sympathetic blockade is confirmed by the presence of Horner's syndrome, which is characterized by constriction of the pupil (miosis) and drooping of the upper eyelid (ptosis). If Horner's syndrome is not observed within 20 minutes of the first injection, the right-sided SGB is repeated one hour later using the same technique. If Horner's syndrome is not confirmed after the second injection, no additional injections are provided.

Trial Locations (1)

43210

The Ohio State University, Columbus

All Listed Sponsors
collaborator

The Stellate Institute

UNKNOWN

collaborator

Navy SEAL Foundation

UNKNOWN

lead

Ohio State University

OTHER

NCT05107752 - Stellate Ganglion Block to Augment Trauma-focused Therapy Among Veterans With PTSD | Biotech Hunter | Biotech Hunter