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Completed

NCT Number: NCT03831581

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

Interventional study that evaluate dermatomal distribution and its demographic determinants in patients who underwent to Erector Spinae Plane (ESP) block

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Key information

Conditions

Pain, Chronic Chronic Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

hospital universitario San Vicente Fundacion

Medellín, Antioquia, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erector Spinae Plane Block

Procedure

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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).

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2019
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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