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Effect of Ultrasound-guided Left Stellate Ganglion Block on Rapid Recovery in Patients With Liver Lobectomy and Its Mechanism

Primary Purpose

Left Stellate Ganglion Block on Rapid Recovery, Possible Molecular Mechanism of Left Stellate Ganglion Block

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stellate ganglion block
Sponsored by
Zhonghua Chen,MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Left Stellate Ganglion Block on Rapid Recovery focused on measuring Guided by ultrasound, Stellate ganglion block, hepatectomy, ERAS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Sixty patients with elective lobectomy; heart function grade I or II;ASA grade I or II;aged 18-70 years.

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Exclusion Criteria:Non-lobectomy patients; age <18 and > 70 years old;heart function grade ≥ III, ASA grade ≥ III; Hypersensitivity to local anesthesia;combined with immune disease or immunosuppression;severe mental illness unable to cooperate with SGB;abnormal neck anatomy;Stellate ganglion block failure;the patient refused to participate in the study.

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Sites / Locations

  • Shaoxing People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

experimental group

Control group

Arm Description

The experimental group was injected with 0.5% ropivacaine 6ml

control group was injected with 6ml normal saline.

Outcomes

Primary Outcome Measures

Postoperative complications
pulmonary infection, oxygenation injury, arrhythmia, bleeding, intestinal paralysis, incision infection, renal insufficiency, cognitive dysfunction, etc.
mortality rate
mortality rate
Plasma concentrations of IL-6,IL-10 and TNF-α
Plasma concentrations of IL-6,IL-10 and TNF-α were measured before operation, 6 h after operation, 24 h after operation, and 72 h after operation

Secondary Outcome Measures

Full Information

First Posted
September 4, 2021
Last Updated
January 11, 2023
Sponsor
Zhonghua Chen,MD
Collaborators
China (Zhejiang) Health technology RESEARCH and development and transformation platform
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1. Study Identification

Unique Protocol Identification Number
NCT05042583
Brief Title
Effect of Ultrasound-guided Left Stellate Ganglion Block on Rapid Recovery in Patients With Liver Lobectomy and Its Mechanism
Official Title
Effect of Ultrasound-guided Left Stellate Ganglion Block on Rapid Recovery in Patients With Liver Lobectomy and Its Mechanism
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhonghua Chen,MD
Collaborators
China (Zhejiang) Health technology RESEARCH and development and transformation platform

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Lobe resection of complex process Traumatic big liver door block causes the body's nervous system very excited or inhibit the endocrine system, immune excessive activation of inflammatory cells, triggering and cause dysfunction of the immune inflammatory reaction, of patients with injury of tissues and organs and affect its repair, increase the risk of complications after liver resection, affected lobe resection in patients with postoperative rapid recovery. Stellate ganglion block has been widely used in the treatment of various systemic diseases due to its advantages of simple operation and obvious effect. SGB has broad application prospects and can promote postoperative recovery of patients undergoing major surgery, but its effect on the rapid recovery of patients undergoing liver lobectomy and its mechanism remain to be further explored.
Detailed Description
Stellate ganglion, also known as cervicothoracic sympathetic ganglion, is a fusion of the subcervical sympathetic ganglion emitted from C3-C7 and the first thoracic sympathetic ganglion, located in the lateral lateral of the transverse tubercle of the 7th cervical vertebra and the cervical protubertion of the first rib, and receives THE T1-T2 nerve SGB, which is mainly manifested in the central and peripheral nerves The central function is to maintain the stability of internal environment by regulating the activity of hypothalamus. The peripheral effect is mainly manifested by blocking the preganglionic and postganglionic fibers, which inhibits the muscle tension, cardiovascular movement and bronchoconstrictor glands in the distribution area to secrete pain conduction, so as to achieve the purpose of treating diseases such as heart, lung, head and neck. The study also found that SGB can regulate the endocrine system autonomic nervous system and immune system, and play an important role in maintaining the stability of the body's internal environment. SGB is considered a very important weapon for modern anesthesiologists. The clinical application of SGB is not only for the pain treatment of head, face, neck, shoulder and limb, but also for the treatment of arrhythmia, traumatic stress and the control of hypertension. SGB has been shown to be effective in treating ventricular arrhythmias, stopping ventricular tachycardia in patients with long QT syndrome, and ventricular fibrillation with recurrent acute myocardial infarction. SGB has a certain therapeutic effect on pulmonary hypertension by down-regulating sympathetic activity and improving endothelial dysfunction. SGB can regulate gastrointestinal dysfunction, promote gastrointestinal motility recovery, and has obvious curative effect on gastrointestinal diseases. Studies have confirmed that SGB can significantly decrease serum inflammatory cytokines IL-1B,IL-6 and TNF-α. Planetary ganglion block in patients with severe trauma showed significant downregulation of inflammatory factors IL-1B,IL-6 and TNF-α in patients with 6, 24 and 72 hours, suggesting that SGB has a regulatory role in the early inflammatory response of trauma and improves the prognosis of acute trauma. SGB can reduce the inflammatory response, improve gastrointestinal dysfunction and promote the recovery of gastrointestinal function after surgery by reducing stress response, inhibiting the synthesis of cytokines inflammatory mediators and nitric oxide synthase

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Stellate Ganglion Block on Rapid Recovery, Possible Molecular Mechanism of Left Stellate Ganglion Block
Keywords
Guided by ultrasound, Stellate ganglion block, hepatectomy, ERAS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sixty patients with liver lobectomy were selected and divided into two groups according to random number table method: experimental group and control group., with 30 cases in each group. All enrolled patients signed informed consent. Control group: The control group was injected with physiological saline 6ml for stellate ganglion block.Experimental group: The experimental group was injected with 0.5% ropivacaine 6ml for stellate ganglion block.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Neither the experimenters nor the participants knew whether they were getting an experimental drug or a placebo. In this way, the description of the therapeutic effects and adverse reactions of the subjects, as well as the record of the various reactions of the experimenters, can be as objective as possible.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
The experimental group was injected with 0.5% ropivacaine 6ml
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
control group was injected with 6ml normal saline.
Intervention Type
Procedure
Intervention Name(s)
Stellate ganglion block
Intervention Description
The probe direction was 30-45 degrees from the sagittal plane of the neck. The anterior nodules of the transverse process of the sixth cervical vertebra were displayed. The important anatomical structures were distinguished, and the internal carotid artery and longus cervical muscle were observed. A 25G, 6cm puncture needle was used with the tip beveled downward, and the needle path and tip were shown under ultrasound. The tip reached the high-echo sieve structure between the carotid artery and longus cervical muscle, and the drug solution was injected after withdrawal without blood and gas . The experimental group was injected with 6ml 0.5% ropivacaine.
Primary Outcome Measure Information:
Title
Postoperative complications
Description
pulmonary infection, oxygenation injury, arrhythmia, bleeding, intestinal paralysis, incision infection, renal insufficiency, cognitive dysfunction, etc.
Time Frame
Within one week after surgery
Title
mortality rate
Description
mortality rate
Time Frame
Within 30 days after surgery
Title
Plasma concentrations of IL-6,IL-10 and TNF-α
Description
Plasma concentrations of IL-6,IL-10 and TNF-α were measured before operation, 6 h after operation, 24 h after operation, and 72 h after operation
Time Frame
Within three days of the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Sixty patients with elective lobectomy; heart function grade I or II;ASA grade I or II;aged 18-70 years. - Exclusion Criteria:Non-lobectomy patients; age <18 and > 70 years old;heart function grade ≥ III, ASA grade ≥ III; Hypersensitivity to local anesthesia;combined with immune disease or immunosuppression;severe mental illness unable to cooperate with SGB;abnormal neck anatomy;Stellate ganglion block failure;the patient refused to participate in the study. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhonghua chen, master's degree
Phone
13625751526
Email
chenbeijing116@163.com
Facility Information:
Facility Name
Shaoxing People's Hospital
City
Shaoxing
State/Province
Zhejiang
ZIP/Postal Code
312000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhonghua chen, master's degree
Phone
18279563090
Email
429065940@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Ultrasound-guided Left Stellate Ganglion Block on Rapid Recovery in Patients With Liver Lobectomy and Its Mechanism

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