Evaluating the benefit to two stellate ganglion blocks with one stellate ganglion block at 12 week review in patients diagnosed with treatment resistant anxiety disorder, who have not responded to standard treatments.

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Dual Stellate Ganglion Block with Local Anaesthetic: The participant will be positioned supine with the head turned to the contralateral side. The skin over the anterolateral aspect of the neck will be prepped with antiseptic solution. At level of cervical C6 vertebrae, the skin and the subcutaneous tissue will be injected with lignocaine. An anterolateral approach will be used after carefully scanning each participant s neck anatomy with Doppler imaging to identify common structures and vascular anomalies. Then, using a 26 gauge needle, the right side of the neck will be accessed with the needle in long axis to the ultrasound transducer. The needle will be visualized under real‐time ultrasound guidance through the sternocleidomastoid muscle continuing just ventral to the tip of the anterior tubercle of C6 until the needle tip penetrates the ventral fascia of longus coli, dorsal to the common carotid artery. Slowly over a minute, nine ml of 0.2 percent ropivacaine will be injected. After 10 minutes, the subject will be examined in a seated position for the presence of Horners syndrome to confirm that the SGB was successful in blocking sympathetic activity on the treated side. The procedure will be repeated on the left side of the neck after 12 hours and within 7 days Intervention2: Dual Stellate Ganglion Block with Local Anaesthetic and Steroid Mixture: The participant will be positioned supine with the head turned to the contralateral side. The skin over the anterolateral aspect of the neck will be prepped with antiseptic solution. At level of cervical C6 vertebrae, the skin and the subcutaneous tissue will be injected with lignocaine. An anterolateral approach will be used after carefully scanning each participant s neck anatomy with Doppler imaging to identify common structures and vascular anomalies. Then, using a 26 gauge needle, the right side of the neck will be accessed with the needle in long axis to the ultrasound transducer. The needle will be visualized under real‐time ultrasound guidance through the sternocleidomastoid muscle continuing just ventral to the tip of the anterior tubercle of C6 until the needle tip penetrates the ventral fascia of longus coli, dorsal to the common carotid artery. Slowly over a minute, nine ml of 0.2 percent ropivacaine and 20 mg of depot methylprednisolone will be injected. After 10 minutes, the subject will be examined in a seated position for the presence of Horners syndrome to confirm that the SGB was successful in blocking sympathetic activity on the treated side. The procedure will be repeated on the left side of the neck after 12 hours and within 7 days Control Intervention1: Right sided Stellate Ganglion Block with Local Anaesthetic: he participant will be positioned supine with the head turned to the contralateral side. The skin over the anterolateral aspect of the neck will be prepped with antiseptic solution. At level of cervical C6 vertebrae, the skin and the subcutaneous tissue will be injected with lignocaine. An anterolateral approach will be used after carefully scanning e CONDITION: Health Condition 1: F411‐ Generalized anxiety disorder PRIMARY OUTCOME: The primary outcome of the study will be to determine the effectiveness of single and dual Stellate Ganglion Block in reducing anxiety in patients with Treatment Resistant Anxiety Disorder as quantified by the Generalized Anxiety Disorder questionnaire at 12 weeks post treatment.Timepoint: Baseline ; 12 weeks post intervention INCLUSION CRITERIA: Adults with treatment resistant anxiety disorder who score 10 or more on GAD7 questionnaire and are willing to consent. SECONDARY OUTCOME: Change in Hair cortisol levels at 12 weeks post intervention when compared to baseline levels between the four groupsTimepoint: Baseline ; 12 weeks post intervention Change in perceived stress scale scores at 12 and 24 weeks post intervention when compared to baseline levels between the four groupsTimepoint: Baseline ; 12 weeks post intervention ; 24 weeks post intervention Change in PGIC score between the four groups at 12 weeks post interventionTimepoint: 12 weeks Change in sleep quality and severity scores at 12 and 24 weeks post intervention when compared to baseline levels between the four groupsTimepoint: Baseline ; 12 weeks post intervention ; 24 weeks post intervention The change in anxiety score as measured on GAD7 questionnaire at 4, 8 and 24 weeks when ; compared to the baselineTimepoint: Baseline ; 4 weeks ; 8 weeks ; 24 weeks
Epistemonikos ID: daa5f360a2ba3934a44165852f9ac4f9f7d4c0d3
First added on: Oct 08, 2026