Evaluation of Dermatomal Distribution in the Erector Spinae Plane (ESP) Block

May 23, 2023 updated by: Universidad de Antioquia
Interventional study that evaluate dermatomal distribution and its demographic determinants in patients who underwent to Erector Spinae Plane (ESP) block

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Hospital Universitario San Vicente Fundación

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erector Spinae Plane Block
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.
Procedure: Erector Spinae Plane Block
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dermatomes with sensitive block
Time Frame: 60 minutes
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.
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight
Time Frame: 60 minutes
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.
60 minutes
Adverse events
Time Frame: 60 minutes and 24 hours
Frequency of adverse events (hypotension, pneumothorax, neurological deficit, bradycardia) after the Erector Spinae Plane (ESP) block.
60 minutes and 24 hours
Success rate
Time Frame: 60 minutes and 24 hours
Success rate (Blocking of at least 2 continuous dermatomes at the puncture site measured with pinprick and cold)
60 minutes and 24 hours
Degree of satisfaction
Time Frame: 60 minutes and 24 hours
Degree of satisfaction evaluated with the Likert scale of 4 points (1 dissatisfied, 2 slightly dissatisfied, 3 slightly satisfied, 4 satisfied).
60 minutes and 24 hours
Visual Analogue Scale (VAS)
Time Frame: 60 minutes and 24 hours
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.
60 minutes and 24 hours
Height
Time Frame: 60 minutes
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.
60 minutes
Age
Time Frame: 60 minutes
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.
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Antioquia

Investigators

  • Study Chair: Adriana Cadavid, Universidad de Antioquia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

February 5, 2019

First Posted (Actual)

February 6, 2019

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UdeA1003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only final results of research

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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