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

Pain, Postoperative Clinical Trial

Official title:

The Effect of Both Ultrasound and Fluoroscopy Guide Erector Spinae Plane Blocks in Patient Undergo Breast Surgery or Pain Intervention Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05044247
• Other study ID #: 202008018RINC
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: September 2021

Study information

• Verified date: September 2020
• Source: National Taiwan University Hospital
• Contact: Wen-Ying Lin
• Phone: 0223220322
• Email: ying434[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic
• Pain, Postoperative

Intervention

Procedure:
• ESP blocks
ultrasound and fluoroscopy to identify the spread of drug

Locations

Country	Name	City	State
Taiwan	National Taiwan University Cancer Center	Taipei county

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scale	reduction of Visual Analogue Scale	12 months