Left Stellate Ganglion Block on Rapid RecoveryNCT05042583
Effect of Ultrasound-guided Left Stellate Ganglion Block on Rapid Recovery in Patients With Liver Lobectomy and Its Mechanism
A study testing Stellate ganglion block in people with Left Stellate Ganglion Block on Rapid Recovery and Possible Molecular Mechanism of Left Stellate Ganglion Block, run by Zhonghua Chen,MD at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Left Stellate Ganglion Block on Rapid Recovery, Possible Molecular Mechanism of Left Stellate Ganglion Block
- What is being tested?
- Stellate ganglion block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
-
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shaoxing People's Hospital
Shaoxing, Zhejiang, 312000
zhonghua chen, master's degree, 18279563090, 429065940@qq.com
About this study
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.
Read the 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
- Conditions
- Left Stellate Ganglion Block on Rapid Recovery, Possible Molecular Mechanism of Left Stellate Ganglion Block
- Being tested
- Stellate ganglion block
- Keywords
- Guided by ultrasound, Stellate ganglion block, hepatectomy, ERAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate ganglion blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The experimental group was injected with 0.5% ropivacaine 6ml Receives: Procedure: Stellate ganglion block |
| Control group | Placebo comparator | control group was injected with 6ml normal saline. Receives: Procedure: Stellate ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
pulmonary infection, oxygenation injury, arrhythmia, bleeding, intestinal paralysis, incision infection, renal insufficiency, cognitive dysfunction, etc.
Measured: Within one week after surgery
mortality rate
mortality rate
Measured: Within 30 days after surgery
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
Measured: Within three days of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Jan 2021
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Stellate Ganglion Block on Rapid RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhonghua Chen,MD
- Sponsor type
- University, hospital or other
- Collaborators
- China (Zhejiang) Health technology RESEARCH and development and transformation platform
- Responsible party
- Sponsor-investigator, Zhonghua Chen,MD, Shaoxing Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042583
- Sponsor's protocol ID
- 1
- Status last verified
- Jan 2023
- First submitted
- 4 Sep 2021
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lao WL, Sang S, Huang LC, Yi SH, Guo MC, Dong HM, Zhou GZ, Chen ZH. Effect of ultrasound-guided stellate ganglion block on inflammatory cytokines and postoperative recovery after partial hepatectomy: a randomised clinical trial. BMC Anesthesiol. 2024 Jan 2;24(1):7. doi: 10.1186/s12871-023-02392-7.
PubMed 38166634
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-guided Left Stellate Ganglion Block on Rapid Recovery in Patients With Liver Lobectomy and Its Mechanism
- ClinicalTrials.gov ID
- NCT05042583
- Acronym / sponsor ID
- 1
- Conditions
- Left Stellate Ganglion Block on Rapid Recovery, Possible Molecular Mechanism of Left Stellate Ganglion Block
- Keywords
- Guided by ultrasound, Stellate ganglion block, hepatectomy, ERAS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhonghua Chen,MDUniversity, hospital or other
- Collaborators
- China (Zhejiang) Health technology RESEARCH and development and transformation platform
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: Stellate ganglion blockThe experimental group was injected with 0.5% ropivacaine 6ml |
| Control group | Placebo comparator | Procedure: Stellate ganglion blockcontrol group was injected with 6ml normal saline. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellate ganglion blockThe 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. | Procedure or surgery | Control group, experimental group |
Primary outcome
Postoperative complications
Time frame: Within one week after surgery
pulmonary infection, oxygenation injury, arrhythmia, bleeding, intestinal paralysis, incision infection, renal insufficiency, cognitive dysfunction, etc.
mortality rate
Time frame: Within 30 days after surgery
mortality rate
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Derived from this study: PubMed 38166634Lao WL, Sang S, Huang LC, Yi SH, Guo MC, Dong HM, Zhou GZ, Chen ZH. Effect of ultrasound-guided stellate ganglion block on inflammatory cytokines and postoperative recovery after partial hepatectomy: a randomised clinical trial. BMC Anesthesiol. 2024 Jan 2;24(1):7. doi: 10.1186/s12871-023-02392-7.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate ganglion block in people with Left Stellate Ganglion Block on Rapid Recovery and Possible Molecular Mechanism of Left Stellate Ganglion Block, run by Zhonghua Chen,MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhonghua chen, master's degree (13625751526, chenbeijing116@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: Within one week after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05042583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.