Pain, Postoperative Clinical Trial
Official title:
Evaluation of Dermatomal Distribution in the Erector Spinae Plane (ESP) Block
Verified date | November 2018 |
Source | Universidad de Antioquia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Interventional study that evaluate dermatomal distribution and its demographic determinants in patients who underwent to Erector Spinae Plane (ESP) block
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 |
Country | Name | City | State |
---|---|---|---|
Colombia | hospital universitario San Vicente Fundacion | Medellin | Antioquia |
Lead Sponsor | Collaborator |
---|---|
Universidad de Antioquia |
Colombia,
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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