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

Not Applicable

Completed

• Conditions: Pain, Chronic; Pain, Postoperative

• Registration Number: NCT03831581
• Lead Sponsor: Universidad de Antioquia

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2018-11
• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-06
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Dermatomes with sensitive block	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 Outcome Measures

Name	Time	Method
weight	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.
Adverse events	60 minutes and 24 hours	Frequency of adverse events (hypotension, pneumothorax, neurological deficit, bradycardia) after the Erector Spinae Plane (ESP) block.
Visual Analogue Scale (VAS)	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.
Height	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.
Success rate	60 minutes and 24 hours	Success rate (Blocking of at least 2 continuous dermatomes at the puncture site measured with pinprick and cold)
Degree of satisfaction	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).
Age	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.

Trial Locations

Locations (1)

hospital universitario San Vicente Fundacion; 🇨🇴 Medellin, Antioquia, Colombia