NCT05531864

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

3.2 years

First QC Date

August 25, 2022

Last Update Submit

February 26, 2024

Conditions

Liver NeoplasmsPostoperative AnalgesiaSerratus Anterior Plane Block

Keywords

serratus anterior plane blockPostoperative analgesialiver cancer

Outcome Measures

Primary Outcomes (4)

  • Block plane

    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

    The visual analogue scale (VAS) of the patient's pain was recorded 24 hours after operation.

    24 hours after surgery

  • visual analogue scale

    The visual analogue scale (VAS) of the patient's pain was recorded 48 hours after operation.

    48 hours after surgery.

  • visual analogue scale

    The visual analogue scale (VAS) of the patient's pain was recorded 36 hours after operation.

    36 hours after surgery.

Secondary Outcomes (4)

  • Patient satisfaction

    48 hours after surgery.

  • Remedial analgesic drug

    24 hours after surgery.

  • Intraoperative blood pressure changes

    2 hours after the beginning of surgery.

  • Intraoperative heart rate changes

    2 hours after the beginning of surgery.

Study Arms (2)

Continuous serratus anterior plane block

EXPERIMENTAL

Ultrasound-guided continuous serratus anterior plane block.

Procedure: Ultrasound-guided continuous low serratus anterior plane block

Single serratus anterior plane block combined with rectus sheath nerve block

ACTIVE COMPARATOR

Ultrasound-guided single serratus anterior plane block combined with rectus sheath nerve block.

Procedure: Ultrasound-guided single serratus anterior plane block

Interventions

Ultrasound-guided continuous low serratus anterior plane blockPROCEDURE

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.

Continuous serratus anterior plane block
Ultrasound-guided single serratus anterior plane blockPROCEDURE

Ultrasound-guided single anterior saw plane block was performed, and a needle was injected between the 4th and 5th costals in the midaxillary line.

Single serratus anterior plane block combined with rectus sheath nerve block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-60 years;
  • ASAI-II;
  • BMI: 18-29 kg/m2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First People's Hospital of Neijiang

Neijiang, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • ailing wu, Doctor

    First People's Hospital of Neijiang.

    STUDY DIRECTOR

Central Study Contacts

Jiang Fei

CONTACT

182832360531277636690@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2022

First Posted

September 8, 2022

Study Start

January 1, 2021

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

We plan to share this research plan with other researchers

Shared Documents
STUDY PROTOCOL
Time Frame
It is expected to be shared in 2023
Access Criteria
article

Locations

CN(1)