Alcohol 70% Versus Chlorhexidine 0.5% in the Spinal Anesthesia Skin Antissepsis

NCT ID: NCT02833376

Last Updated: 2017-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-30
• Study Completion Date: 2017-01-30

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.

Conditions

Anesthesia, Spinal; Anesthesia, Epidural; Antisepsis

Keywords

microbiota; ethanol; chlorhexidine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Alcohol group

Patients allocated to this group will receive skin antisepsis with alcohol 70% prior spinal anesthesia

Group Type: EXPERIMENTAL

alcohol antisepsis

Intervention Type: OTHER

Chlorhexidine group

Patients allocated to this group will receive skin antisepsis with alcoholic solution of chlorhexidine 0.5% prior spinal anesthesia

Group Type: EXPERIMENTAL

chlorhexidine antisepsis

Intervention Type: OTHER

Interventions

alcohol antisepsis

Intervention Type: OTHER

chlorhexidine antisepsis

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade do Vale do Sapucai

OTHER

Sponsor Role: lead

Responsible Party

Luiz Carlos Tostes

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniela F Veiga, MD, PhD

Role: STUDY_CHAIR

Universidade do Vale do Sapucai

Ana Beatriz A Loyola, PhD

Role: STUDY_DIRECTOR

Universidade do Vale do Sapucai

Locations

Hospital e Maternidade Santa Paula

Pouso Alegre, Minas Gerais, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 33470369 (View on PubMed)

Other Identifiers

MPLCT

Identifier Type: -

Identifier Source: org_study_id