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

Completed · Not applicable · Has a placebo group

Conditions studied: PostTraumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT03077919

Run by

RTI International

People needed

113

Starts

2016-05-25

Expected to finish

2018-06-09

Last updated by the study team

2020-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tripler Army Medical Center (TAMC) — Honolulu, Hawaii, United States
• Womack Army Medical Center (WAMC) — Fort Bragg, North Carolina, United States
• Landstuhl Regional Medical Center (LRMC) — Landstuhl, Germany

Full record on ClinicalTrials.gov

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