The Effect of Stellate Ganglion Block on Insomnia Patients

NCT ID: NCT06255730

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-28
• Study Completion Date: 2024-06-30

Brief 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.

Detailed 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.

Conditions

Insomnia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stellate Ganglion Block Group

Stellate Ganglion Block Group will be given Stellate Ganglion Block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g), once a day

Group Type: EXPERIMENTAL

Stellate Ganglion Block

Intervention Type: PROCEDURE

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.

Lidocaine Hydrochloride

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Other Intervention Names

Stellate Ganglion Block

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zeng Changhao

OTHER

Sponsor Role: lead

Responsible Party

Zeng Changhao

Research Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nieto Luis, Master

Role: STUDY_CHAIR

Site Coordinator of United Medical Group

Locations

Center Rehabilitation Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Qianyun Lu, Master

Role: CONTACT

luqianyun@126.com

15333866454

Weiji Zhao, Master

Role: CONTACT

zwjww2009@163.com

17839973473

Facility Contacts

Wei Liu, Master

Role: primary

Other Identifiers

SGB shimian old

Identifier Type: -

Identifier Source: org_study_id