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

January 11, 2023 updated by: Zhonghua Chen,MD
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Shaoxing, Zhejiang, China, 312000
        • Recruiting
        • Shaoxing people's Hospital
        • Contact:
          • zhonghua chen, master's degree
          • Phone Number: 18279563090
          • Email: 429065940@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group
The experimental group was injected with 0.5% ropivacaine 6ml
Procedure: Stellate ganglion block
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.
Placebo Comparator: Control group
control group was injected with 6ml normal saline.
Procedure: Stellate ganglion block
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: Within one week after surgery
pulmonary infection, oxygenation injury, arrhythmia, bleeding, intestinal paralysis, incision infection, renal insufficiency, cognitive dysfunction, etc.
Within one week after surgery
mortality rate
Time Frame: Within 30 days after surgery
mortality rate
Within 30 days after surgery
Plasma concentrations of IL-6,IL-10 and TNF-α
Time Frame: Within three days of the surgery
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
Within three days of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhonghua Chen,MD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
China (Zhejiang) Health technology RESEARCH and development and transformation platform

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1 (Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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