CClinicalTrials.gg
RecruitingNCT06255730Updated Mar 12, 2024

The Effect of Stellate Ganglion Block on Insomnia Patients

An interventional study of Stellate Ganglion Block and Lidocaine Hydrochloride in Insomnia, sponsored by Zeng Changhao. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by Zeng Changhao · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    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

    Procedure: Stellate Ganglion Block · Drug: Lidocaine Hydrochloride

Interventions

  • ProcedureStellate 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.

  • DrugLidocaine 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.

    Also known as: Stellate Ganglion Block

05

What researchers measure

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.

    Time frame: day 1 and day 10

Secondary outcomes

  1. 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 α-coefficient of 0.879.

    Time frame: day 1 and day 10

  2. 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.

    Time frame: day 1 and day 10

06

Study locations

1 of 1 sites recruiting
  • Center Rehabilitation Hospital
    Seoul, Korea, Republic of
    • Wei Liu, Master · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06255730
Lead sponsor
Zeng Changhao
Responsible party
Zeng Changhao (Research Director, People's Hospital of Zhengzhou University) — Sponsor-investigator
First posted
Feb 13, 2024
Start date
Feb 28, 2024
Primary completion
Jun 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Mar 12, 2024

Study contacts

Qianyun Lu, Master
Contact
luqianyun@126.com
15333866454
Weiji Zhao, Master
Contact
zwjww2009@163.com
17839973473
Nieto Luis, Master
study chair · Site Coordinator of United Medical Group

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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