NCT05889741

Combining Stellate Ganglion Block With Prolonged Exposure for PTSD

Combining Stellate Ganglion Block With Prolonged Exposure for PTSD: A Randomized Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to compare the combination of Massed Prolonged Exposure (PE); a behavioral therapy for PTSD) and a stellate ganglion block (SGB; an injection of a local anesthetic into the front of the neck) with Massed Prolonged Exposure and a sham injection in a sample of military service members or retirees with PTSD. The main questions it aims to answer are: (1) Does the addition of an SGB improve treatment outcomes associated with Massed PE and (2) Do differences in psychophysiological arousal during the exposure portion of treatment help explain treatment outcomes for PTSD. Participants will receive ten 90-minute session of Massed PE. Between the first and second Massed PE sessions, half of the participants will receive a SGB, and half will receive a sham SGB.

Detailed description

Massed PE will be conducted by master-level or doctoral-level therapists. Participants will meet with their providers for individual, 90-minute sessions. They will then be asked to complete out-of-session treatment assignments throughout the rest of the day. Between the individual therapy session and out-of-session treatment assignments, participants will engage in approximately four to six hours of treatment per day, Monday through Friday, for two weeks. Each participant will also be offered three booster sessions at 1-, 3-, and 7-weeks posttreatment. The stellate ganglion block injection or the sham SGB will be administered between the first and second massed PE session by qualified medical personnel as per standard operating procedure for the placement of a stellate ganglion block. A research nurse will be in attendance during the procedure and for an hour recovery period following the block administration. Assessments will be administered at pretreatment, during treatment, at posttreatment, and at 1-, 3-, and 6-months following the completion of PE. The primary outcome assessment will be 1-month following the completion of PE. Following this assessment, participants randomized to the sham SGB arm of the study will be offered an SGB with ropivacaine.

Conditions

• Stress Disorders, Post-Traumatic

Interventions

Type	Name	Description
DRUG	Ropivacaine injection	6.5cc of Ropivacaine hydrochloride (HCl) 0.5%, one time into the stellate ganglion
DRUG	Normal saline	6.5cc of Normal Saline one time into the stellate ganglion.

Timeline

• Start date: 2024-02-26
• Primary completion: 2027-03-31
• Completion: 2027-08-31
• First posted: 2023-06-05
• Last updated: 2025-09-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study