Augmenting Massed Prolonged Exposure With a Stellate Ganglion Block to Treat PTSD

• Status: Active, not recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a small, open-label treatment study that tests the potential safety and treatment effectiveness of a stellate ganglion block combined with Massed Prolonged Exposure (PE). Each of the 12 participants will receive ten 90-minute sessions of Massed Prolonged Exposure and an injection of a stellate ganglion block between the first and second PE sessions.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: United States Department of Defense
• Treatments: Ropivacaine

Criteria

Inclusion Criteria:

1. Active duty or retired military service member (age 18- 65 years)

2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5)

3. Able to speak and read English (due to standardization of outcome measures)

4. Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at Brooke Army Medical Center for the stellate ganglion block.

Exclusion Criteria:

1. Classification as high risk for suicide

2. Current serious mental health diagnosis (e.g., bipolar or psychosis)

3. Symptoms of moderate to severe substance (to include alcohol) use within the last 30 days

4. Pregnancy (i.e. positive pregnancy test at screening) or breastfeeding

5. Current anticoagulant use

6. History of bleeding disorder

7. Infection or mass at injection site

8. Myocardial infarction within 6 months of procedure

9. Pathologic bradycardia or irregularities of heart rate or rhythm;

10. Symptomatic hypotension

11. Phrenic or laryngeal nerve palsy

12. History of glaucoma

13. Uncontrolled seizure disorder

14. History of allergy to local anesthetics