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The Effect of Both Ultrasound and Fluoroscopy Guide Erector Spinae Plane Blocks

Primary Purpose

Pain, Chronic, Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ESP blocks
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Thirty-five patients in each group of breast tumor surgery and pain intervention procedure patients.
  2. Age > 20

Exclusion Criteria:

  1. Unable to complete questionnaires.
  2. With coagulopathy
  3. History of thoracic spine trauma or surgery.
  4. Allergy to contrast local anesthetics and medium (Iohexol)

Sites / Locations

  • National Taiwan University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ESP block

Arm Description

ESP block under mixed local anesthetics, betamethasone agent

Outcomes

Primary Outcome Measures

Pain scale
reduction of Visual Analogue Scale

Secondary Outcome Measures

Full Information

First Posted
September 5, 2021
Last Updated
September 22, 2021
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05044247
Brief Title
The Effect of Both Ultrasound and Fluoroscopy Guide Erector Spinae Plane Blocks
Official Title
The Effect of Both Ultrasound and Fluoroscopy Guide Erector Spinae Plane Blocks in Patient Undergo Breast Surgery or Pain Intervention Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Since the original publication on the erector spinae plane (ESP) block in 2016, the technique of the ESP block has evolved significantly in the last few years. Current reports suggest that the ESP block provides adequate analgesia in thoracic and abdominal sites in a post-surgical and chronic pain patient. However, there were still inconsistencies and unclear spread of local anesthetics in ultrasound guide ESP block. This study focusing on the spread of local anesthetic in ESP block under ultrasound and fluoroscopy and possible mechanisms of action.
Detailed Description
The erector spinae plane (ESP) block was first described by Forero et al. Considering the spread of local anesthetic in the ESP block, it can block more extensive spinal nerves. Therefore, since the first publication, the ESP block has been reported as an effective analgesic for several types of pain and has been used mainly in thoracic surgery. It also used in abdominal surgery, nephrectomy, hernia surgery, and hip surgery, among others. Additionally, the ESP block used not only acute pain management but also chronic pain management. The spread of local anesthetic in the ESP block investigated in several ways, such as computed tomography (CT) imaging of cadavers, fluoroscopy, chest radiography, and patients' CT imaging. These investigations show that local anesthetics in the ESP block spread to the upper and lower sides of the interfascial plane between the erector spine muscle and the underlying transverse process. Additionally, the local anesthetic spreads beyond the transverse process to reach the costotransverse junctions, after which it permeates the paravertebral space. Despite the many publications on ESP blocks, there are still inconsistencies and unclear aspects of the technique, such as the spread of local anesthetic and action mechanisms This study focuses on the spread of local anesthetic in ESP block under ultrasound and fluoroscopy and possible mechanisms of action.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESP block
Arm Type
Experimental
Arm Description
ESP block under mixed local anesthetics, betamethasone agent
Intervention Type
Procedure
Intervention Name(s)
ESP blocks
Intervention Description
ultrasound and fluoroscopy to identify the spread of drug
Primary Outcome Measure Information:
Title
Pain scale
Description
reduction of Visual Analogue Scale
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Thirty-five patients in each group of breast tumor surgery and pain intervention procedure patients. Age > 20 Exclusion Criteria: Unable to complete questionnaires. With coagulopathy History of thoracic spine trauma or surgery. Allergy to contrast local anesthetics and medium (Iohexol)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Ying Lin
Phone
0223220322
Ext
38133
Email
ying434@gmail.com
Facility Information:
Facility Name
National Taiwan University Cancer Center
City
Taipei county
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Ying Lin

12. IPD Sharing Statement

Learn more about this trial

The Effect of Both Ultrasound and Fluoroscopy Guide Erector Spinae Plane Blocks

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