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Clinical trial

The Effect of Stellate Ganglion Block on Insomnia Patients: a Pre - and Post Control Experiments

ID
Name
SGB shimian old
Description
A prospective study was conducted on Insomnia Patients. All the patients were provided with Stellate Ganglion Block. The quality of sleep was evaluated to see if Stellate Ganglion Block can improve Insomnia.
Trial arms
Trial start
2024-02-28
Estimated PCD
2024-06-01
Trial end
2024-06-01
Status
Recruiting
Treatment
Stellate Ganglion Block
the patients in the observation group were provided with Stellate Ganglion Block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). The percutaneous approach via the paratracheal route was used for Stellate Ganglion Block. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.
Arms:
Stellate Ganglion Block Group
Lidocaine Hydrochloride
the patients in the observation group were provided with Stellate Ganglion Block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). The percutaneous approach via the paratracheal route was used for Stellate Ganglion Block. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.
Arms:
Stellate Ganglion Block Group
Other names:
Stellate Ganglion Block
Size
50
Primary endpoint
Pittsburgh Sleep Quality Index
day 1 and day 10
Eligibility criteria
Inclusion Criteria: * Insomnia patients with the ages over 18. * Meeting the diagnostic criteria for chronic insomnia as per the International Classification of Sleep Disorders (ICSD) or the Diagnostic and Statistical Manual of Mental Disorders (DSM). * Experiencing insomnia symptoms persistently for at least three months. * Not currently using or ceased using medication for insomnia for at least four weeks. * Willing to undergo Stellate Ganglion Block treatment and participate in the study. Exclusion Criteria: * Patients with severe cardiovascular disease, pulmonary disease, or other serious physical health issues. * Pregnant or lactating women. * Patients with mental disorders (such as major depression, anxiety disorders, schizophrenia, etc.) or cognitive impairments. * Patients with known allergies or contraindications to Stellate Ganglion Block treatment. * Patients currently participating in other clinical trials or receiving experimental treatments.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-03-12

1 organization

1 product

1 indication

Organization
Zeng Changhao
Product
Lidocaine
Indication
Insomnia