Stress Disorders, Post-Traumatic study: Ropivacaine injection vs Normal saline
Official title Combining Stellate Ganglion Block With Prolonged Exposure for PTSD
ClinicalTrials.gov ID: NCT05889741
What this study is testing
What is Ropivacaine injection?
This is an investigational local anesthetic injection being studied to see if it helps with PTSD symptoms when used with therapy. It is designed to temporarily block nerve signals in the neck area to reduce physical stress responses.
Also referred to as Naropin.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a neck injection makes talk therapy work better for PTSD. It also looks at how body stress levels affect the results.
- Who it's for
- You may be able to join if you are a military veteran with PTSD.
- What's involved
- You would get ten 90-minute talk therapy sessions. You would also get one injection in your neck. Half of people get real medicine, and half get a pretend shot.
- Time commitment
- The study involves ten therapy sessions and one injection visit.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Active duty and retired military service members ages 18-65 years
- PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale
- Able to speak and read English (due to standardization of outcome measures)
- Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at a military treatment facility (MTF) where the stellate ganglion...
You likely can't join if
- Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale and the...
- Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgment)
- Symptoms of moderate to severe substance use (to include alcohol) warranting immediate intervention based on clinical judgment.
- Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment
- Pregnancy or breastfeeding
- Current anticoagulant use
See the full eligibility criteria
- Active duty and retired military service members ages 18-65 years
- PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale
- Able to speak and read English (due to standardization of outcome measures)
- Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at a military treatment facility (MTF) where the stellate ganglion block will be placed.
- Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale and the Self-Injurious Thoughts and Behaviors Interview short form) and...
- Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgment)
- Symptoms of moderate to severe substance use (to include alcohol) warranting immediate intervention based on clinical judgment.
- Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment
- Pregnancy or breastfeeding
- Current anticoagulant use
- History of bleeding disorder
- Infection or mass at injection site
- Myocardial infarction within 6 months of procedure
- Pathologic bradycardia or irregularities of heart rate or rhythm
- Symptomatic hypotension
- Phrenic or laryngeal nerve palsy
- History of glaucoma
- Uncontrolled seizure disorder
- History of allergy to local anesthetics
- Current use of Class III antiarrhythmics
The study team makes the final eligibility decision.
Where it is enrolling
- Fort Hood, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Fort Hood, Texas, United States; San Antonio, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.