Pain, ChronicNCT05044247
The Effect of Both Ultrasound and Fluoroscopy Guide Erector Spinae Plane Blocks
A study testing ESP blocks in people with Pain, Chronic and Pain, Postoperative, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pain, Chronic, Pain, Postoperative
- What is being tested?
- ESP blocks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Apr 2021to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thirty-five patients in each group of breast tumor surgery and pain intervention procedure patients.
- Age > 20
Who cannot join
- Unable to complete questionnaires.
- With coagulopathy
- History of thoracic spine trauma or surgery.
- Allergy to contrast local anesthetics and medium (Iohexol)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Cancer Center
Taipei County
Wen-Ying Lin
About this study
Official title: The Effect of Both Ultrasound and Fluoroscopy Guide Erector Spinae Plane Blocks in Patient Undergo Breast Surgery or Pain Intervention Procedures
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.
Read the 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.
- Conditions
- Pain, Chronic, Pain, Postoperative
- Being tested
- ESP blocks
- Medical subject headings
- Chronic Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP blocksProcedure or surgery
ultrasound and fluoroscopy to identify the spread of drug
| Study group | Role | What they receive |
|---|---|---|
| ESP block | Experimental | ESP block under mixed local anesthetics, betamethasone agent Receives: Procedure: ESP blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scale
reduction of Visual Analogue Scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start20 Apr 2021
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044247
- Sponsor's protocol ID
- 202008018RINC
- Status last verified
- Sep 2020
- First submitted
- 5 Sep 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Both Ultrasound and Fluoroscopy Guide Erector Spinae Plane Blocks in Patient Undergo Breast Surgery or Pain Intervention Procedures
- ClinicalTrials.gov ID
- NCT05044247
- Acronym / sponsor ID
- 202008018RINC
- Conditions
- Pain, Chronic, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESP block | Experimental | Procedure: ESP blocksESP block under mixed local anesthetics, betamethasone agent |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Thirty-five patients in each group of breast tumor surgery and pain intervention procedure patients.
- Age > 20
Key exclusion criteria (4 listed)
- Unable to complete questionnaires.
- With coagulopathy
- History of thoracic spine trauma or surgery.
- Allergy to contrast local anesthetics and medium (Iohexol)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESP blocksultrasound and fluoroscopy to identify the spread of drug | Procedure or surgery | ESP block |
Primary outcome
Pain scale
Time frame: 12 months
reduction of Visual Analogue Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESP blocks in people with Pain, Chronic and Pain, Postoperative, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Ying Lin (0223220322 ext. 38133, ying434@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021; AzTrials last refreshed its copy on 7 Nov 2026.