NCT05042583

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

2.6 years

First QC Date

September 4, 2021

Last Update Submit

January 11, 2023

Conditions

Keywords

Guided by ultrasoundStellate ganglion blockhepatectomyERAS

Outcome Measures

Primary Outcomes (3)

  • Postoperative complications

    pulmonary infection, oxygenation injury, arrhythmia, bleeding, intestinal paralysis, incision infection, renal insufficiency, cognitive dysfunction, etc.

    Within one week after surgery

  • mortality rate

    mortality rate

    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

    Within three days of the surgery

Study Arms (2)

experimental group

EXPERIMENTAL

The experimental group was injected with 0.5% ropivacaine 6ml

Procedure: Stellate ganglion block

Control group

PLACEBO COMPARATOR

control group was injected with 6ml normal saline.

Procedure: Stellate ganglion block

Interventions

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.

Control groupexperimental group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaoxing People's Hospital

Shaoxing, Zhejiang, 312000, China

RECRUITING

Related Publications (1)

  • 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.

Central Study Contacts

zhonghua chen, master's degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

September 4, 2021

First Posted

September 13, 2021

Study Start

January 1, 2021

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

January 13, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations