The Effect of Stellate Ganglion Block on Insomnia Patients

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06255730
• Other study ID #: SGB shimian old
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: People's Hospital of Zhengzhou University
• Contact: Qianyun Lu, Master
• Phone: 15333866454
• Email: luqianyun[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Insomnia is a sleep disorder characterized by difficulty falling asleep, staying asleep, or experiencing non-restorative sleep, despite having adequate opportunity for sleep. It is a common condition that can significantly impact an individual's quality of life and overall well-being.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Procedure:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Center Rehabilitation Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Zeng Changhao

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Sleep Quality Index	Pittsburgh Sleep Quality Index (PSQI): The PSQI is a widely used scale that assesses sleep quality, including aspects such as sleep latency, sleep duration, sleep efficiency, sleep disturbances, and daytime dysfunction. The total score ranges from 0 to 21, with higher scores indicating worse sleep quality.	day 1 and day 10
Secondary	Anxiety	The anxiety was assessed using the Generalized Anxiety Disorder-7, including items related to fear, worry, attention, etc. The total score ranged from 0 to 21, which was positively correlated with potential anxiety. In the previous study, the scale demonstrated a Cronbach's a-coefficient of 0.879.	day 1 and day 10
Secondary	Sleep Impairment Index	Sleep Impairment Index (SII): The SII is a scale that measures the impact of sleep disorders on daily functioning. It includes nine items, covering aspects such as feeling unwell in the morning and feeling tired during the day. The total score ranges from 0 to 36, with higher scores indicating more severe sleep impairment.	day 1 and day 10