The Effect of Stellate Ganglion Block on Insomnia Patients

NCT06255730 | Recruiting

• 1 other identifier: SGB shimian old
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anxiety

  day 1 and day 10

• Sleep Impairment Index

  day 1 and day 10

Study Arms (1)

Stellate Ganglion Block Group

EXPERIMENTAL

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

Procedure: Stellate Ganglion Block; Drug: Lidocaine Hydrochloride

Interventions

Stellate Ganglion Block 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.

Stellate Ganglion Block Group

Lidocaine Hydrochloride 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.

Also known as: Stellate Ganglion Block

Stellate Ganglion Block Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeng Changhao: lead

Study Sites (1)

Center Rehabilitation Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group

  STUDY CHAIR

Central Study Contacts

Qianyun Lu, Master

CONTACT

15333866454; luqianyun@126.com

Weiji Zhao, Master

CONTACT

17839973473; zwjww2009@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 13, 2024
• Study Start: February 28, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)