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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

160

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Liu Di

Investigators

  • 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)

January 1, 2021

Primary Completion (Estimated)

February 29, 2024

Study Completion (Estimated)

February 29, 2024

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

September 3, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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