Trial document




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  DRKS00015817

Trial Description

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Title

Stellate ganglion block in patients with borderline personality disorder and posttraumatic stress disorder

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The blocking of the stellate ganglion (SGB) is a well-proven and frequent applied method in pain therapy. The stellate ganglion is a nerval communication point of the sympathetic network (autonomic nervous system) and recieves input from the paravertebral sympathetic chain. The departing nerve fibres follow the arterial vessels to their impact point in the head, face and upper extremities. Stellate ganglion blocks with local anesthetic lead to a preponderance of the parasympathetic network over sympathetic network.
The effectiveness of a SGB in post-traumatic stress disorder (PTSD) and in borderline personality disorder (BPD) is not well studied, yet.
In this study we are investigating the effectiveness of a SGB in patients with PTSD and BPD. We expect a reduction of dissociative symptoms and inner tension in patients with routine treatment combined with SGB in contrast to patients without the intervention (SGB). Further we want to investigate the effectiveness on wound healing after self-injury in upper extremities. We expect a positive effect on wound healing caused by improved circulation.
The SGB is executed with ultrasonic assistance by a physician experienced in pain treatment. The reduction of the symptoms was measured by standardized questionnaires.

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Brief Summary in Scientific Language

The blocking of the stellate ganglion (SGB) is a well-proven and frequent applied method in pain therapy. The stellate ganglion is a nerval communication point of the sympathetic network (autonomic nervous system) and recieves input from the cervical paravertebral sympathetic chain. The efferent nerve fibres follow the arterial vessels to their impact point in the head, face and upper extremities. Stellate ganglion blocks with local anesthetic lead to a preponderance of the parasympathetic network over sympathetic network.
The effectiveness of a SGB in post-traumatic stress disorder (PTSD) and in borderline personality disorder (BPD) is not well studied, yet.
In this study we are investigating the effectiveness of a SGB in patients with PTSD and BPD. We expect a reduction of dissociative symptoms and inner tension in patients with routine treatment (Dialectical Behavioral Therapy, Bohus et al. 2004) combined with SGB in contrast to patients without the intervention (SGB). Further we want to investigate the effectiveness on wound healing after self-injury in upper extremities. We expect a positive effect on wound healing caused by improved circulation.
The SGB is executed with ultrasonic assistance by a physician experienced in pain treatment. The reduction of the symptoms was measured by standardized questionnaires: Dissociations-Tension-Scale-4 (DSS-4), Clinical Global Impression Skala (CGI), Beck-Depression-Inventar (BDI), Borderline-Symptom-List-23 (BSL-23), State-Trait-Anxiety-inventory-S (STAI-S), Questionaire of dissociativ symptoms (FDS), PTSD Checklist for DSM-5 (PCL-5), Symptom-Checklist-90-R (SCL-90-R), Patient and Observer Scare Assesment Scale (POSAS).

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Organizational Data

  •   DRKS00015817
  •   2018/10/31
  •   [---]*
  •   yes
  •   Approved
  •   2018-559N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F60.31 -  [generalization F60.3: Emotionally unstable personality disorder]
  •   F43.1 -  Post-traumatic stress disorder
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Interventions/Observational Groups

  •   Stationary patients with posttraumatic stress disorder and borderline personality disorder recieve in addition to a standard therapy (dialectical behavorial therapy, after week 4) a series of 8 stellate ganglion block (2 per week) on both sides, with each 3 ml Ropivacain 1%. During every meeting the patient has to fill up the Dissociations-Tension-Scale-4 (DSS-4) and the Clinical Global Impression Skala (CGI). Once per week the Beck-Depression-Inventar (BDI), Borderline-Symptom-List-23 (BSL-23), State-Trait-Anxiety-inventory-S (STAI-S), PTSD Checklist for DSM-5 (PCL-5) and the Patient and Observer Scare Assessment Scale (POSAS). Before and after the intervention series the patient has to fill up the Questionnaire of dissociative symptoms (FDS) and the Symptom-Checklist-90-R (SCL-90-R).
  •   Stationary patients with posttraumatic stress disorder and borderline personality disorder recieve the same procedure as in arm 1 without the stellate ganglion block.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Reduction of dissociative symptoms and inner tension in patients with routine treatment (Dialectical Behavioral Therapy, Bohus et al. 2004) combined with ultrasound guided SGB (Stellate Ganglion Blocks) in contrast to patients without the intervention (SGB).
The effectivness is measured with standardized questionars: every meeting Dissociations-Tension-Scale-4 (DSS-4) and the Clinical Global Impression Skala (CGI). Once per week the Beck-Depression-Inventar (BDI), Borderline-Symptom-List-23 (BSL-23), State-Trait-Anxiety-inventory-S (STAI-S), PTSD Checklist for DSM-5 (PCL-5). Before and after the intervention series the patient has to fill up the Questionnaire of dissociative symptoms (FDS) and the Symptom-Checklist-90-R (SCL-90-R).

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Secondary Outcome

Further we want to investigate the effectiveness on wound healing after self-injury in upper extremities with a standardized questionaire: Patient and Observer Scare Assessment Scale (POSAS).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/01/02
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   50   Years
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Additional Inclusion Criteria

Diagnosis of a borderline personality disorder (5 criteria DSM) + perhaps posttraumatic stress disorder
Age of 18 to 50 years
voluntary consent

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Exclusion Criteria

chronic pain
Bipolar-I-disorder or schizophrenia
Cognitive impairment
Allergies on local anesthetics
Intake of oral anticoagulants

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Addresses

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    • Klinik für Anästhesiologie und Operative Intensivmedizin, Schmerzzentrum,Universitätsmedizin Mannheim
    • Mr.  Prof. Dr. med.  Justus  Benrath 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Klinik für Anästhesiologie und Operative Intensivmedizin, Schmerzzentrum,Universitätsklinik Mannheim
    • Ms.  Dipl.-Psych.  Boo Young  Chung 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Klinik für Anästhesiologie und Operative Intensivmedizin, SchmerzzentrumUniversitätsklinik Mannheim
    • Mr.  Dr. med.  Benjamin  Gerber 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Medizinische Fakultät Mannheim der Universität Heidelberg
    • Mr.  Christian  Jörg 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Psychosomatik und Psychotherapeutische Medizin, Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. Dr. med.  Christian  Schmahl 
    • K 3, 21
    • 68159  Mannheim
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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