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The Effects of Three Different Ultrasound-guided Nerve Blocks in VATS

Primary Purpose

Thoracic Anesthesia, Nerve Block, Pain, Acute

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Paravertebral block
ESP block
MTP block
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Anesthesia focused on measuring ultrasound-guided nerve block, postoperative pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • selective lobetomy under VATS
  • ASA classfication 1-3

Exclusion Criteria:

  • history of thoracic surgery
  • double lateral VATS
  • allergy to local anesthetics
  • coagulation disorders
  • severe heart diseases, hepatic or renal insufficiency
  • a history of chronic pain or chronic opioid use
  • psychiatric disease or uncooperative
  • BMI>28 kg/m2
  • VATS transfered to open thoractomy

Sites / Locations

  • Tongji Hospital, Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

paravertebral block

ESP block

MTP block

Arm Description

Patients receive ultrasound-guided paravertebral block

Patients receive ultrasound-guided erector spinae plane (ESP) block

Patients receive ultrasound-guided mid-point transverse process to pleura (MTP) block

Outcomes

Primary Outcome Measures

postoperative morphine consumption
The dose is according to the record from PCA pump

Secondary Outcome Measures

Pain score at rest
measured by VAS (0-10)
Pain score while coughing
measured by VAS (0-10)

Full Information

First Posted
March 30, 2021
Last Updated
April 13, 2022
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04829409
Brief Title
The Effects of Three Different Ultrasound-guided Nerve Blocks in VATS
Official Title
The Effects of Ultrasound-guided Mid-point Transverse Process to Pleura Block, Erector Spinae Plane Block and Paravertebral Block on Postoperative Pain in Video-assisted Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Ultrasound-guided mid-point transverse process to pleura block, erector spinae plane block and paravertebral block are three different methods of nerve block, used for relieving postoperative pain in thoracic anesthesia. This study is to compare them on block effects, postoperative pain and analgesic consumption in video-assisted thoracic surgery.
Detailed Description
Ultrasound-guided nerve block is an important part of multi-mode analgesia to decrease the consumption of opioids. Thoracic paravertebral block is considered as an ideal regional analgesic choice for video-assisted thoracic surgery, but it still has some side effects, such as pneumothorax, vascular injury, especially for novices. Recent years, ultrasound-guided mid-point transverse process to pleura block and erector spinae plane block are reported for thoracic surgery. The insertion depth in these two methods is more superficial than traditional paravertebral block. They could have less side effects. Therefore, we design a randomised control study to compare them on block effects, postoperative pain and analgesic consumption in video-assisted thoracic surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Anesthesia, Nerve Block, Pain, Acute
Keywords
ultrasound-guided nerve block, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
paravertebral block
Arm Type
Active Comparator
Arm Description
Patients receive ultrasound-guided paravertebral block
Arm Title
ESP block
Arm Type
Active Comparator
Arm Description
Patients receive ultrasound-guided erector spinae plane (ESP) block
Arm Title
MTP block
Arm Type
Experimental
Arm Description
Patients receive ultrasound-guided mid-point transverse process to pleura (MTP) block
Intervention Type
Procedure
Intervention Name(s)
Paravertebral block
Intervention Description
Patients receive ultrasound-guided paravertebral block
Intervention Type
Procedure
Intervention Name(s)
ESP block
Intervention Description
Patients receive ultrasound-guided erector spinae plane (ESP) block
Intervention Type
Procedure
Intervention Name(s)
MTP block
Intervention Description
Patients receive ultrasound-guided mid-point transverse process to pleura (MTP) block
Primary Outcome Measure Information:
Title
postoperative morphine consumption
Description
The dose is according to the record from PCA pump
Time Frame
postoperative 24 hours
Secondary Outcome Measure Information:
Title
Pain score at rest
Description
measured by VAS (0-10)
Time Frame
at 0, 8, 24 hour after surgery
Title
Pain score while coughing
Description
measured by VAS (0-10)
Time Frame
at 0, 8, 24 hour after surgery
Other Pre-specified Outcome Measures:
Title
block level
Description
measured by pin-prick at clavicle midline
Time Frame
20 minutes after block
Title
intraoperative analgesic comsumption
Description
the dose of sufentanil, remifentanil
Time Frame
intraoperative, from induction to emergence from anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: selective lobetomy under VATS ASA classfication 1-3 Exclusion Criteria: history of thoracic surgery double lateral VATS allergy to local anesthetics coagulation disorders severe heart diseases, hepatic or renal insufficiency a history of chronic pain or chronic opioid use psychiatric disease or uncooperative BMI>28 kg/m2 VATS transfered to open thoractomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenlong Yao, MD
Phone
86-27-83663173
Email
wlyao82@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ailin Luo, MD,PhD
Organizational Affiliation
Tongji Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji Hospital, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ailin Luo, Ph.D.,M.D.
Phone
+86-27-83663282
Email
alluo@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Wenlong Yao, Ph.D.,M.D.

12. IPD Sharing Statement

Learn more about this trial

The Effects of Three Different Ultrasound-guided Nerve Blocks in VATS

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