Stellate Ganglion Block in the Treatment of Posttraumatic Stress Disorder
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ClinicalTrials.gov Identifier: NCT05427500 |
Recruitment Status :
Not yet recruiting
First Posted : June 22, 2022
Last Update Posted : June 22, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
PTSD | Drug: 5 mL of 0.5% preservative-free bupivacaine | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Stellate Ganglion Block in the Treatment of Posttraumatic Stress Disorder: Outcome Evaluation, Mechanism of Action, and Integration in Care - A Phase III Randomized Controlled Trial |
Estimated Study Start Date : | September 1, 2022 |
Estimated Primary Completion Date : | September 1, 2023 |
Estimated Study Completion Date : | September 1, 2023 |
Arm | Intervention/treatment |
---|---|
Single SGB
This arm will receive a single 5 mL dose of 0.5% preservative-free bupivacaine.
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Drug: 5 mL of 0.5% preservative-free bupivacaine
IV will be inserted. Patient will be connected to cardiorespiratory monitors. The neck will be cleansed twice. A high frequency (15-6 MHz) linear ultrasound probe will be used to identify the arteries, jugular vein, and other important vasculature. Once a clear path for the needle is identified, the skin is anesthetized. A cutting tip spinal needle is then inserted at the lateral aspect of the field and advanced in-plane under ultrasound visualization. A test injection is injected to verify placement, then 5 mL of 0.5% preservative-free bupivacaine will be injected. Per standard SGB procedure, vitals will be measured post-SGB and participants will remain in the clinic for approximately 15 minutes to monitor for any serious adverse events.
Other Name: SteriMax Bupivicaine |
Repeated SGB
This arm will receive two 5 mL doses of 0.5% preservative-free bupivacaine.
|
Drug: 5 mL of 0.5% preservative-free bupivacaine
IV will be inserted. Patient will be connected to cardiorespiratory monitors. The neck will be cleansed twice. A high frequency (15-6 MHz) linear ultrasound probe will be used to identify the arteries, jugular vein, and other important vasculature. Once a clear path for the needle is identified, the skin is anesthetized. A cutting tip spinal needle is then inserted at the lateral aspect of the field and advanced in-plane under ultrasound visualization. A test injection is injected to verify placement, then 5 mL of 0.5% preservative-free bupivacaine will be injected. Per standard SGB procedure, vitals will be measured post-SGB and participants will remain in the clinic for approximately 15 minutes to monitor for any serious adverse events.
Other Name: SteriMax Bupivicaine |
- Monitoring patient response and remission of PTSD symptoms [ Time Frame: 2 years ]Proportion of patients showing response (at least 10-point reduction) and remission (total score < 33) in symptoms of PTSD on PCL-5
- Monitoring patient improvement on Clinician Administered PTDS Scale for DSM-5 (CAPS-5) [ Time Frame: 2 years ]Proportion of patients showing response (at least 10-points reduction) and loss of diagnosis on CAPS-5
- Monitoring patient improvement in symptom burden and functioning [ Time Frame: 2 years ]Proportion of patients achieving reliable change (at least 14-point reduction) in the total score on OQ45.2 reflecting improvement in symptom burden and functioning
- Changes from baseline in hypervigilance [ Time Frame: 2 years ]Measured by the Brief Hypervigilance Scale
- Changes from baseline in anxiety [ Time Frame: 2 years ]Measured by the Overall Anxiety Severity Impairment Scale
- Changes from baseline in depression [ Time Frame: 2 years ]Measured by the Quick Inventory of Depressive Symptomatology
- Changes from baseline in pain scale scores [ Time Frame: 2 years ]Measured by the Brief Pain Inventory
- Ratings of participant satisfaction and recommendations for future use of SGB [ Time Frame: 2 years ]Measured by qualitative self report scale
- Changes in participant's symptomatology and overall functioning from the perspective of the participant's family and support network [ Time Frame: 2 years ]Measured by Family And Support Team-Questionnaire
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Ages Eligible for Study: | 18 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Consistent with our current sex representation in the OSI clinic, we will be recruiting 20% females, corresponding to 9 female participants, and 45 male participants |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of PTSD according to DSM-5 criteria with prominent and persistent cluster E hyperarousal symptoms
- Age 18-69 years
- Under care of a mental health clinician
- Not benefited from adequate trials of pharmacological or psychological evidence-based treatment and/or a preference and consent for a trial of SGB
Exclusion Criteria:
- Assessed with high risk for suicide in the last 30 days (per patient's treating clinician at OSI clinic)
- Diagnosis of bipolar or psychotic disorder
- Moderate to severe substance use within the last 30 days (based on chart and verbal report from patient)
- In process of disability assessment or legal action
- Moderate or severe TBI (based on chart and verbal report from patient)
- Pregnancy or breastfeeding
- Current anticoagulant use (eligible if can be held before the procedure)
- History of bleeding disorder (based on chart and verbal report from patient)
- Infection, mass or anatomic abnormalities at target injection site
- Myocardial infarction within 6 months of procedure (based on chart and verbal report from patient)
- Pathologic bradycardia or irregularities of heart rate or rhythm (based on chart and verbal report from patient)
- Symptomatic hypotension (BP<90/60 + clinical symptoms of hypotension)
- Phrenic or laryngeal nerve palsy (based on chart and verbal report from patient)
- History of glaucoma (based on chart and verbal report from patient)
- Uncontrolled seizure disorder (based on chart and verbal report from patient)
- Known history of allergy to local anesthetics (based on chart and verbal report from patient)
- Severe COPD (based on chart and verbal report from patient)
- Pneumothorax (based on chart and verbal report from patient)
- Contralateral pneumonectomy or non-functional lung (based on chart and verbal report from patient)
- Active systemic infection (based on chart and verbal report from patient)
- Patient refusal/inability to tolerate procedure/positioning
- Contraindication to MR imaging
- Any other condition that in the opinion of the investigator could create a hazard to the participant's safety, endanger the study procedures, or interfere with the interpretation of study results.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05427500
Contact: Rebecca Gomez, MD | 613-722-6521 ext 6916 | Rebecca.Gomez@theroyal.ca | |
Contact: Jakov Shlik, MD | 613-722-6521 ext 6272 | jakov.shlik@theroyal.ca |
Principal Investigator: | Rebecca Gomez, MD | Psychiatrist at the OSI Clinic at the Royal Ottawa Mental Health Centre |
Responsible Party: | Rebecca Gomez, MD, Psychiatrist, The Royal's Institute of Mental Health Research |
ClinicalTrials.gov Identifier: | NCT05427500 |
Other Study ID Numbers: |
2022001 |
First Posted: | June 22, 2022 Key Record Dates |
Last Update Posted: | June 22, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Stellate Gangllion Block Canadian Armed Forces Veterans Royal Canadian Mounted Police |
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Mental Disorders Bupivacaine Anesthetics, Local |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |