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

Primary Purpose

Liver Neoplasms, Postoperative Analgesia, Serratus Anterior Plane Block

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ultrasound-guided continuous low serratus anterior plane block
Ultrasound-guided single serratus anterior plane block
Sponsored by
Liu Di
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Neoplasms focused on measuring serratus anterior plane block, Postoperative analgesia, liver cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First People's Hospital of NeijiangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous serratus anterior plane block

Single serratus anterior plane block combined with rectus sheath nerve block

Arm Description

Ultrasound-guided continuous serratus anterior plane block.

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

Outcomes

Primary Outcome Measures

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.
visual analogue scale
The visual analogue scale (VAS) of the patient's pain was recorded 24 hours after operation.
visual analogue scale
The visual analogue scale (VAS) of the patient's pain was recorded 48 hours after operation.
visual analogue scale
The visual analogue scale (VAS) of the patient's pain was recorded 36 hours after operation.

Secondary Outcome Measures

Patient satisfaction
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
Remedial analgesic drug
Whether other analgesic drugs were added within 24 hours after operation was recorded
Intraoperative blood pressure changes
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.
Intraoperative heart rate changes
The curve of the change of the operative heart rate was recorded through the anesthesia machine.

Full Information

First Posted
August 25, 2022
Last Updated
September 3, 2022
Sponsor
Liu Di
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1. Study Identification

Unique Protocol Identification Number
NCT05531864
Brief Title
Ultrasound-guided Continuous Low Serratus Anterior Plane Block in Hepatocellular Carcinoma Surgery
Acronym
RCT
Official Title
The Role of Continuous Low Serratus Anterior Plane Block in Hepatocellular Carcinoma Surgery: a Randomised Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Liu Di

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasms, Postoperative Analgesia, Serratus Anterior Plane Block
Keywords
serratus anterior plane block, Postoperative analgesia, liver cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous serratus anterior plane block
Arm Type
Experimental
Arm Description
Ultrasound-guided continuous serratus anterior plane block.
Arm Title
Single serratus anterior plane block combined with rectus sheath nerve block
Arm Type
Active Comparator
Arm Description
Ultrasound-guided single serratus anterior plane block combined with rectus sheath nerve block.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided continuous low serratus anterior plane block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided single serratus anterior plane block
Intervention Description
Ultrasound-guided single anterior saw plane block was performed, and a needle was injected between the 4th and 5th costals in the midaxillary line.
Primary Outcome Measure Information:
Title
Block plane
Description
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.
Time Frame
30 minute after the surgery begins
Title
visual analogue scale
Description
The visual analogue scale (VAS) of the patient's pain was recorded 24 hours after operation.
Time Frame
24 hours after surgery
Title
visual analogue scale
Description
The visual analogue scale (VAS) of the patient's pain was recorded 48 hours after operation.
Time Frame
48 hours after surgery.
Title
visual analogue scale
Description
The visual analogue scale (VAS) of the patient's pain was recorded 36 hours after operation.
Time Frame
36 hours after surgery.
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
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
Time Frame
48 hours after surgery.
Title
Remedial analgesic drug
Description
Whether other analgesic drugs were added within 24 hours after operation was recorded
Time Frame
24 hours after surgery.
Title
Intraoperative blood pressure changes
Description
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.
Time Frame
2 hours after the beginning of surgery.
Title
Intraoperative heart rate changes
Description
The curve of the change of the operative heart rate was recorded through the anesthesia machine.
Time Frame
2 hours after the beginning of surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-60 years; ASAI-II; BMI: 18-29 kg/m2 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Fei
Phone
18283236053
Ext
1
Email
1277636690@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ailing wu, Doctor
Organizational Affiliation
First People's Hospital of Neijiang.
Official's Role
Study Director
Facility Information:
Facility Name
The First People's Hospital of Neijiang
City
Neijiang
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hengchun Shen, master
Phone
15599237557

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
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Ultrasound-guided Continuous Low Serratus Anterior Plane Block in Hepatocellular Carcinoma Surgery

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