Ultrasound-guided Continuous Low Serratus Anterior Plane Block in Hepatocellular Carcinoma Surgery (RCT)

February 26, 2024 updated by: Liu Di

The Role of Continuous Low Serratus Anterior Plane Block in Hepatocellular Carcinoma Surgery: a Randomised Clinical Trial.

To investigate the clinical application of ultrasound-guided continuous low serratus anterior plane block in open surgery for hepatocellular carcinoma.

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

METHODS: Patients with hepatocellular carcinoma who attended our hospital from January 2021 to April 2023 were divided into CS group and N group according to the random number table method; CS group underwent ultrasound-guided continuous low anterior serratus plane block and N group underwent ultrasound-guided single anterior serratus plane block combined with rectus abdominis sheath block; the operation time, anesthesia time, incision length, sensory block time and sensory block maintenance time were counted and recorded. Pain score (NRS) was used to detect analgesia; alanine aminotransferase (ALT), liver function aspartate aminotransferase (AST), and prothrombin time (The time of thrombin, NRS) were measured by fluorescent quantitative PCR. （The time of thrombin (APTT), total bilirubin (TBIL) levels and adverse reactions.

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 (Estimated)

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.
160

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
    • Sichuan
      • Neijiang, Sichuan, China
        • Recruiting
        • The First People's Hospital of Neijiang
        • Contact:
          • Hengchun Shen, master
          • Phone Number: 15599237557

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-60 years;
  2. ASAI-II;
  3. BMI: 18-29 kg/m2

Exclusion Criteria:

  1. Combined cardiac, cerebral, hepatic, and renal failure;
  2. Comorbid psychiatric and neuromuscular disorders;
  3. A history of allergy to anesthetic drugs;
  4. Participation in other recent clinical or drug trials.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Continuous serratus anterior plane block
Ultrasound-guided continuous serratus anterior plane block.
Procedure: Ultrasound-guided continuous low serratus anterior plane block
Low anterior serratus plane block, move the mid-axillary line 4 and 5 intercostal puncture points are moved down and the puncture is changed to 7 and 8 intercostal.
Active Comparator: Single serratus anterior plane block combined with rectus sheath nerve block
Ultrasound-guided single serratus anterior plane block combined with rectus sheath nerve block.
Procedure: Ultrasound-guided single serratus anterior plane block
Ultrasound-guided single anterior saw plane block was performed, and a needle was injected between the 4th and 5th costals in the midaxillary line.

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
Block plane
Time Frame: 30 minute after the surgery begins
The effect of anesthesia after ultrasound-guided nerve block was measured using planimetry, as well as the area being anesthetized. The chest wall between T2-T9 and ice cotton balls was used to assess the extent and extent of anesthesia block.
30 minute after the surgery begins
visual analogue scale
Time Frame: 24 hours after surgery
The visual analogue scale (VAS) of the patient's pain was recorded 24 hours after operation.
24 hours after surgery
visual analogue scale
Time Frame: 48 hours after surgery.
The visual analogue scale (VAS) of the patient's pain was recorded 48 hours after operation.
48 hours after surgery.
visual analogue scale
Time Frame: 36 hours after surgery.
The visual analogue scale (VAS) of the patient's pain was recorded 36 hours after operation.
36 hours after surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 48 hours after surgery.
The patient's satisfaction with the analgesia 2 days after surgery was recorded. The analgesic effect: 1-3 as satisfactory, 4-6 as unsatisfactory, 7-10 as ineffective
48 hours after surgery.
Remedial analgesic drug
Time Frame: 24 hours after surgery.
Whether other analgesic drugs were added within 24 hours after operation was recorded
24 hours after surgery.
Intraoperative blood pressure changes
Time Frame: 2 hours after the beginning of surgery.

Blood pressure changes were measured directly by radial artery puncture and recorded.

The changes in blood pressure and heart rate before and after excision and the use of intraoperative opioids.
2 hours after the beginning of surgery.
Intraoperative heart rate changes
Time Frame: 2 hours after the beginning of surgery.
The curve of the change of the operative heart rate was recorded through the anesthesia machine.
2 hours after the beginning of 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.
Liu Di

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ailing wu, Doctor, First People's Hospital of Neijiang.

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 (Estimated)

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.
February 29, 2024

Study Completion (Estimated)

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.
February 29, 2024

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).
August 25, 2022

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 3, 2022

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 8, 2022

Study Record Updates

Last Update Posted (Estimated)

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.
February 28, 2024

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.
February 26, 2024

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.
February 1, 2024

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.
  • JF20PJ288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share this research plan with other researchers

IPD Sharing Time Frame

It is expected to be shared in 2023

IPD Sharing Access Criteria

article

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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