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
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.
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.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 50 is below the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Zeng Changhao is the lead sponsor of 59 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Jun 2024, 4 months after the start.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 4 months is below that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
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Studies of the drug tested here: Lidocaine
Sleep Initiation and Maintenance Disorders →
Zeng Changhao