A Randomized, Sham-procedure-controlled, Blinded Study to Evaluate the Effectiveness and Acceptability of Right-sided Stellate Ganglion Block for Treatment of Posttraumatic Stress Disorder Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 3
- 主要终点
- Clinician Administered PTSD Score (CAPS-5) TSSS
研究概览
简要总结
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.
详细描述
Study intervention will be administered at week 0 and at week 2. Injections will be performed under ultrasound visualization. The study medication will be either 7-10 mL 0.5% ropivacaine injected ventral to the right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia at the level of the C6 anterior tubercle (landmarks for the stellate ganglion) (active study medication) or 1-2 mL preservative free normal saline injected anterolateral to the anterior tubercle of C6 (sham procedure). The participant will not be informed which treatment he or she has received and the interaction of the participant and treating physician will be scripted as much as possible. Following the intervention, the treating physician should have no further contact with the participant except as required for participant safety.
Participants will be evaluated for posttraumatic stress disorder (PTSD) symptomatology prior to week 0 and at 8 weeks using the Diagnostic and Statistical Manual (DSM-5) Clinician-Administered PTSD Scale (CAPS-5). They will complete the PTSD Checklist for DSM-5 (PCL-5), the PTSD Checklist - Civilian Version (PCL-C), and the Mini-international Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items at 0, 2, 4, 6, and 8 weeks; they also will complete the M.I.N.I.-Plus items at screening. The 12 item short form survey (SF-12), generalized anxiety disorder 7-item (GAD-7), patient health questionnaire (PHQ-9), K6, Alcohol Use Disorder Identification Test (AUDIT-C/AUDIT), and a short pain scale will be completed at weeks 0, 4, and 8.
Data collected at baseline and 8 weeks will be the primary focus of data analysis. Data collected at other time points will be analyzed as appropriate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Stellate Ganglion Block (SGB)
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
干预措施: Ropivacaine (Drug)
Sham Treatment
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
干预措施: Sham treatment (Drug)
结局指标
主要结局
Clinician Administered PTSD Score (CAPS-5) TSSS
时间窗: Baseline, 8-weeks
≥ 10 point mean Clinician-Administered PTSD Scale for DSM 5 (CAPS 5) total symptom severity scores (TSSS) improvement from baseline to 8 weeks, adjusted for site and baseline TSSS (planned a priori), following paired SGB at 0 and 2 weeks. On the CAPS 5, the range for TSSS is 0 to 80, with higher scores indicating worse PTSD symptomatology. The CAPS-5 is a 30-item structured interview, administered by a credentialed behavioral health practitioner, that corresponds to the DSM-5 criteria for PTSD (Weathers et al. 2013, The Clinician Administered PTSD Scale for DSM-5, Boston MA: The National Center for PTSD).
次要结局
- PTSD Checklist Civilian (PCL-C)(Baseline, 8-weeks)
- Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C)(Baseline, 8-weeks)
- Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items(Baseline, 8-weeks)
- Kessler Psychiatric Distress Scale (K6)(Baseline, 8-weeks)
- The Patient Health Questionnaire (PHQ-9)(Baseline, 8-weeks)
- PTSD Checklist (PCL-5)(Baseline, 8-weeks)
- 12-item Short Form Survey (SF-12) of Physical Functioning(Baseline, 8-weeks)
- Short Pain Scale(Baseline, 8-weeks)
- 12 Item Short Form Survey (SF-12) of Mental Functioning(Baseline, 8-weeks)
- Current Medications(Baseline, 8-weeks)
- Generalized Anxiety Disorder 7-item Survey (GAD-7)(Baseline, 8-weeks)