Clinical trial NCT02833376: Alcohol 70% Versus Chlorhexidine 0.5% in the Spinal Anesthesia Skin Antissepsis
Official title: Alcohol 70% Versus Chlorhexidine 0.5% in the Spinal Anesthesia Skin Antissepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Spinal
Anesthesia, Epidural
Antisepsis
Keywords: microbiota
ethanol
chlorhexidine
Lead sponsor: Universidade do Vale do Sapucai
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Context: The neuraxial blocks, spinal anesthesia and epidural anesthesia are among the most frequently performed procedures worldwide, and despite the advancements of medical equipment, remain dependent on experience and practice of the anesthesiologists. Although antisepsis takes part of the daily routine, there are still no solid scientific evidence of the most appropriate antiseptic for these procedures.

Objective: To compare the 70% alcohol and 0.5% chlorhexidine alcohol solution in skin antisepsis for the neuraxial blocks.

Methods: This is a clinical trial, a prospective, randomized study. There will be selected, consecutively, 70 patients candidates for neuraxial blocks. Patients will be randomly assigned to group A (n = 35), in which the antisepsis will be performed with alcohol 70%, and to group B (n = 35), in which the antiseptic will be performed with the 0.5% chlorhexidine in alcoholic solution. Samples will be collected with swabs in an area of 25 cm² for bacterial cultures three times: in pre-antisepsis moments, in the second minute after antisepsis, and immediately after the puncture. The number of colonies forming units per square centimeter (CFU / cm²) will be counted. The data will be analyzed statistically.


Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 65 years of age , without restriction as to sex, ethnicity, education or social class;
* Patients who are undergoing neuraxial blockade by indicating the anesthesiologist responsible for the procedure

Exclusion Criteria:

* comorbidities or conditions which constitute a contraindication for the neuroaxial block ;
* Body mass index (BMI ) greater than 30 kg / m2;
* Ongoing infection;
* Use of antibiotics in the last seven days;
* Skin lesions at the puncture site ;
* Refusal to participate.

Primary outcomes:
measure: Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)
timeFrame: Before antisepsis
measure: Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)
timeFrame: 2 minutes after antisepsis
measure: Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)
timeFrame: After the Puncture and at most 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Hospital e Maternidade Santa Paula
state: Minas Gerais
Study officials:
affiliation: Universidade do Vale do Sapucai
name: Daniela F Veiga, MD, PhD
role: STUDY_CHAIR
affiliation: Universidade do Vale do Sapucai
name: Ana Beatriz A Loyola, PhD
role: STUDY_DIRECTOR
References:
citation: Tostes LCS, Loyola ABAT, Fraga AO, Gazzi LA, Paiva LF, Juliano Y, Veiga DF. Alcohol (70%) versus alcoholic chlorhexidine solution (0.5%) in skin antisepsis for neuraxial blocks: a randomized clinical trial. Rev Col Bras Cir. 2021 Jan 13;48:e20202633. doi: 10.1590/0100-6991e-20202633. eCollection 2021.