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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831581
• Other study ID #: UdeA1003
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic
• Pain, Postoperative

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