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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03831581
Other study ID # UdeA1003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date October 31, 2018

Study information

Verified date November 2018
Source Universidad de Antioquia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date October 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Colombia hospital universitario San Vicente Fundacion Medellin Antioquia

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 60 minutes
Secondary 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. 60 minutes
Secondary Adverse events Frequency of adverse events (hypotension, pneumothorax, neurological deficit, bradycardia) after the Erector Spinae Plane (ESP) block. 60 minutes and 24 hours
Secondary Success rate Success rate (Blocking of at least 2 continuous dermatomes at the puncture site measured with pinprick and cold) 60 minutes and 24 hours
Secondary Degree of satisfaction 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
Secondary 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. 60 minutes and 24 hours
Secondary 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. 60 minutes
Secondary 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. 60 minutes
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