Effectiveness and Acceptability of Stellate Ganglion Block for Posttraumatic Stress Disorder Symptoms - Effectiveness

• Status: Completed
• Trial end date: 2018-06-09
• Target enrollment: 0
• Participant gender: All

Summary

This is a multisite, randomized, blinded, sham-procedure-controlled study to evaluate the efficacy of right-sided stellate ganglion block (SGB) on the acute symptomatology of Post traumatic Stress Disorder (PTSD), evaluated by the Clinician-Administered PTSD Scale (CAPS-5) clinical interview at pre-treatment and at 8 weeks. This entry describes the effectiveness study.The acceptability study is described in a separate entry.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RTI International
• Collaborators: Landstuhl Regional Medical Center; Tripler Army Medical Center; Womack Army Medical Center
• Treatments: Ropivacaine

Criteria

Inclusion Criteria:

• Member of the Army on active duty status

• Personal access to Internet

• Anticipated stable assignment to installation for at least 2 months

• Stable dosing for ≥3 months, if receiving psychotropic medications

• Prior to enrollment, offered PTSD treatment using A-level modality (as defined by U.S. Army Medical Command (MEDCOM) policy 14-094; 18 Dec 2014).

• PTSD Checklist - Civilian (PCL-C) score of 32 or greater at screening

• Acceptable clinically indicated preoperative laboratory studies, per standard site-specific protocols

Exclusion Criteria:

• Prior Stellate Ganglion Block (SGB)

• Allergy to amide local anesthetics (e.g., ropivacaine, bupivacaine)

• Pregnancy (evaluated by urine test pre-procedure)

• Current anticoagulant use

• History of a bleeding disorder

• Infection or mass at injection site

• Myocardial infarction within 6 months of procedure

• Phrenic or laryngeal nerve palsy (hoarseness)

• History of glaucoma

• History of schizophrenia, other psychotic disorder, bipolar disorder, or personality disorder (axis 2)

• Moderate or severe traumatic brain injury

• Symptoms of moderate to severe substance use disorder in past 30 days

• Suicidal ideation in the past 2 months, documented by the M.I.N.I.-Plus Suicidality Items

• Any ongoing other major life stressor or condition not listed here that the site Investigator believes clearly would place the participant at risk for injury or a poor outcome