Back to resultsEvaluation of Dermatomal Distribution in the Erector Spinae Plane (ESP) Block
Primary Purpose
Pain, Chronic, Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Chronic focused on measuring Erector Spinae Plane, Erector Spinae Plane Block
Eligibility Criteria
Inclusion Criteria:
- Patients older than 18 years, in the acute / chronic pain service that presents pain in the thoracic region and / or upper hemiabdomen.
Exclusion Criteria:
- Women in pregnancy
- Patients with less than 50 Kg of weight
- Dissent of informed consent
Sites / Locations
- hospital universitario San Vicente Fundacion
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Erector Spinae Plane Block
Arm Description
Patients with chest pain or upper abdomen underwent Erector Spinae Plane Block guided by ultrasound, bupivacaine 0.5% 20 ml was administered in the interfascial plane between the transverse process of T5 and the erector muscles of the spine, 60 minutes after dermatomes distribution was evaluated with pinprick and cold.
Outcomes
Primary Outcome Measures
Dermatomes with sensitive block
Number (average) of dermatomes with sensitive block with pinprick and cold achieved at 60 minutes after the Erector Spinae Plane (ESP) block with 20 ml of bupivacaine 0.5%. Also, observe the distribution pattern.
Secondary Outcome Measures
weight
weight in kilograms and its correlation with the main result The variables were grouped in means (standard deviation) for continuous variables and frequencies (percentages) for categorical variables.
Adverse events
Frequency of adverse events (hypotension, pneumothorax, neurological deficit, bradycardia) after the Erector Spinae Plane (ESP) block.
Success rate
Success rate (Blocking of at least 2 continuous dermatomes at the puncture site measured with pinprick and cold)
Degree of satisfaction
Degree of satisfaction evaluated with the Likert scale of 4 points (1 dissatisfied, 2 slightly dissatisfied, 3 slightly satisfied, 4 satisfied).
Visual Analogue Scale (VAS)
Change From Baseline in Pain Scores on the Visual analogue scale (VAS) from 1 to 10 at 60 minutes and 24 hours after the ESP block.
Height
Height in meters and its correlation with the main result The variables were grouped in means (standard deviation) for continuous variables and frequencies (percentages) for categorical variables.
Age
Age in years and its correlation with the main result The variables were grouped in means (standard deviation) for continuous variables and frequencies (percentages) for categorical variables.
Full Information
NCT ID
NCT03831581
First Posted
January 14, 2019
Last Updated
May 23, 2023
Sponsor
Universidad de Antioquia
1. Study Identification
Unique Protocol Identification Number
NCT03831581
Brief Title
Evaluation of Dermatomal Distribution in the Erector Spinae Plane (ESP) Block
Official Title
Evaluation of Dermatomal Distribution in the Erector Spinae Plane (ESP) Block
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad de Antioquia
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
Interventional study that evaluate dermatomal distribution and its demographic determinants in patients who underwent to Erector Spinae Plane (ESP) block
Detailed Description
Interventional study that evaluate dermatomal distribution with pinprick and cold, and its demographic determinants in patients who underwent to Erector Spinae Plane (ESP) block with 20 ml of bupivacaine 0.5% at the thoracic level in patients with pain in the thorax and upper abdomen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Pain, Postoperative
Keywords
Erector Spinae Plane, Erector Spinae Plane Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Assignment interventional
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erector Spinae Plane Block
Arm Type
Experimental
Arm Description
Patients with chest pain or upper abdomen underwent Erector Spinae Plane Block guided by ultrasound, bupivacaine 0.5% 20 ml was administered in the interfascial plane between the transverse process of T5 and the erector muscles of the spine, 60 minutes after dermatomes distribution was evaluated with pinprick and cold.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
In patients with chest pain, ultrasound-guided Erector Spinae Plane Block block was performed at T5 transverse process in the cephalo-caudal direction with Tuohy 18 gauge needle in plane until the needle tip was located in the interfascial plane between the transverse process and the erector spinae muscles, 20 ml of bupivacaine 0.5% was administered and a catheter was inserted if indicated.
Primary Outcome Measure Information:
Title
Dermatomes with sensitive block
Description
Number (average) of dermatomes with sensitive block with pinprick and cold achieved at 60 minutes after the Erector Spinae Plane (ESP) block with 20 ml of bupivacaine 0.5%. Also, observe the distribution pattern.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
weight
Description
weight in kilograms and its correlation with the main result The variables were grouped in means (standard deviation) for continuous variables and frequencies (percentages) for categorical variables.
Time Frame
60 minutes
Title
Adverse events
Description
Frequency of adverse events (hypotension, pneumothorax, neurological deficit, bradycardia) after the Erector Spinae Plane (ESP) block.
Time Frame
60 minutes and 24 hours
Title
Success rate
Description
Success rate (Blocking of at least 2 continuous dermatomes at the puncture site measured with pinprick and cold)
Time Frame
60 minutes and 24 hours
Title
Degree of satisfaction
Description
Degree of satisfaction evaluated with the Likert scale of 4 points (1 dissatisfied, 2 slightly dissatisfied, 3 slightly satisfied, 4 satisfied).
Time Frame
60 minutes and 24 hours
Title
Visual Analogue Scale (VAS)
Description
Change From Baseline in Pain Scores on the Visual analogue scale (VAS) from 1 to 10 at 60 minutes and 24 hours after the ESP block.
Time Frame
60 minutes and 24 hours
Title
Height
Description
Height in meters and its correlation with the main result The variables were grouped in means (standard deviation) for continuous variables and frequencies (percentages) for categorical variables.
Time Frame
60 minutes
Title
Age
Description
Age in years and its correlation with the main result The variables were grouped in means (standard deviation) for continuous variables and frequencies (percentages) for categorical variables.
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients older than 18 years, in the acute / chronic pain service that presents pain in the thoracic region and / or upper hemiabdomen.
Exclusion Criteria:
Women in pregnancy
Patients with less than 50 Kg of weight
Dissent of informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Cadavid
Organizational Affiliation
Universidad de Antioquia
Official's Role
Study Chair
Facility Information:
Facility Name
hospital universitario San Vicente Fundacion
City
Medellin
State/Province
Antioquia
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only final results of research
Citations:
PubMed Identifier
32517405
Citation
Barrios A, Camelo J, Gomez J, Forero M, Peng PWH, Visbal K, Cadavid A. Evaluation of Sensory Mapping of Erector Spinae Plane Block. Pain Physician. 2020 Jun;23(3):E289-E296.
Results Reference
derived
Learn more about this trial
Evaluation of Dermatomal Distribution in the Erector Spinae Plane (ESP) Block
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