Ropivacaine injection
Drug6.5cc of Ropivacaine hydrochloride (HCl) 0.5%, one time into the stellate ganglion
Other names: Naropin
NCT Number: NCT05889741
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 2
Carl R. Darnall Army Medical Center, Fort Hood, Texas, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
6.5cc of Ropivacaine hydrochloride (HCl) 0.5%, one time into the stellate ganglion
Other names: Naropin
6.5cc of Normal Saline one time into the stellate ganglion.
Time frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments
A 30-item structured interview used to assess change symptoms of PTSD. Questions target the onset and duration of symptoms, subjective distress, impact on social and occupational functioning. Total severity scores range from 0 to 80 with higher score indicative of greater PTSD severity. The measure can also be used to confirm the presence of a PTSD diagnosis.
Time frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments
A 20-item self-report measure that assesses the presence and change in severity of PTSD symptoms using the Diagnostic and Statistical Manual of mental disorders (DSM-5). Total severity scores range from 0 to 80 with higher score indictive of greater PTSD severity.
Time frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments
A 9-item self-report measure that assesses the presence and change in severity of depressive symptoms. Total scores range from 0 to 27 with higher scores reflective of greater severity.
Time frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments
A 9-item self-report measure that assesses the presence and change in severity of general anxiety symptoms. Total scores range from 0 to 21 with higher scores reflective of greater severity.
Time frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments
A 36-item self-report measure that assesses change in self-blame, negative cognitions about self, and negative cognitions about the world following trauma exposure. Total scores range from 33 to 231 with higher scores reflective of more problematic cognitions.
Time frame: Two weeks
Change in Psychophysiological data collected from a smart watch measuring galvanic skin response
Time frame: Two weeks
Change in Psychophysiological data collected from a smart watch measuring skin temperature
Time frame: Two weeks
Change in Psychophysiological data collected from a smart watch measuring heart rate
Time frame: Two weeks
Change in Psychophysiological data collected from a smart watch measuring interbeat interval
Time frame: Two weeks
Change in Psychophysiological data collected from a smart watch measuring three-dimensional accelerometer movement
Time frame: Two weeks
Change in Psychophysiological data collected from a smart watch measuring electrodermal activity
Time frame: Two weeks
Change in Psychophysiological data collected from a smart watch measuring photoplethysmography
Contact information is provided by the study sponsor or research team.
The University of Texas Health Science Center at San Antonio
Other
Combining Stellate Ganglion Block With Prolonged Exposure for PTSD: A Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06000475
Mental Disorders, Stress Disorders, Post-Traumatic
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT06852469
Mental Disorders, Stress Disorders, Post-Traumatic
San Diego, California, United States
View Trial DetailsNCT07632131
Cardiopulmonary Bypass, Intensive Care Units
Fuzhou, Fujian, China
View Trial DetailsNCT04793776
Aberrant Motor Behavior in Dementia, Aggression
Tampa, Florida, United States
View Trial Details