Anesthesia, SpinalNCT02833376

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

A study testing alcohol antisepsis and chlorhexidine antisepsis in people with Anesthesia, Spinal and Anesthesia, Epidural, run by Universidade do Vale do Sapucai at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Anesthesia, Spinal, Anesthesia, Epidural, Antisepsis
What is being tested?: alcohol antisepsis and chlorhexidine antisepsis
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteBrazil
Study dates: 30 May 2016to 30 Jan 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital e Maternidade Santa Paula
Pouso Alegre, Minas Gerais, 37550-000

Other trials in Brazil

About this study

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
Being tested: alcohol antisepsis, chlorhexidine antisepsis
Keywords: microbiota, ethanol, chlorhexidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

alcohol antisepsisOther
chlorhexidine antisepsisOther

Study groups in NCT02833376
Study group	Role	What they receive
Alcohol group	Experimental	Patients allocated to this group will receive skin antisepsis with alcohol 70% prior spinal anesthesia Receives: Other: alcohol antisepsis
Chlorhexidine group	Experimental	Patients allocated to this group will receive skin antisepsis with alcoholic solution of chlorhexidine 0.5% prior spinal anesthesia Receives: Other: chlorhexidine antisepsis

What is being measured

The primary outcome is the main question the study is designed to answer.

Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)
The material will be collected in a pre determined field of 25 cm², with a swab, and the maximum seeding in 8 hours, 48 hours after will be counted the number of colonies forming units per square centimeter (CFU/cm²)
Measured: Before antisepsis
Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)
The material will be collected in a pre determined field of 25 cm², with a swab, and the maximum seeding in 8 hours, 48 hours after will be counted the number of colonies forming units per square centimeter (CFU/cm²)
Measured: 2 minutes after antisepsis
Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)
The material will be collected in a pre determined field of 25 cm², with a swab, and the maximum seeding in 8 hours, 48 hours after will be counted the number of colonies forming units per square centimeter (CFU/cm²)
Measured: After the Puncture and at most 40 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 201630 Jan 2017

First posted14 Jul 2016 (estimated)
Study start30 May 2016
Primary completion6 Jan 2017
Study completion30 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02833376
Sponsor's protocol ID: MPLCT
Status last verified: Jul 2016
First submitted: 5 Jul 2016
Last updated: 13 Dec 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 33470369

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Patient-controlled Remimazolam Sedation Under Spinal Anesthesia
Hip Arthroplasty, Spinal Anesthesia
Not yet recruitingPhase 4
Two Doses of IV Magnesium Sulfate for Prevention of Post-Spinal Shivering
Post Spinal Anesthesia Shivering
RecruitingPhase 4
Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
Active, not recruiting
Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery
Maternal Hypotension After Spinal Anesthesia
Not yet recruitingPhase 4
Effects of Ondansetron Timing During Spinal Anesthesia for Urologic Surgery
Spinal Anesthesia-Induced Hypotension, Cerebral Oxygenation

All Anesthesia, Spinal trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Alcohol 70% Versus Chlorhexidine 0.5% in the Spinal Anesthesia Skin Antissepsis
ClinicalTrials.gov ID: NCT02833376
Acronym / sponsor ID: MPLCT
Conditions: Anesthesia, Spinal, Anesthesia, Epidural, Antisepsis
Keywords: microbiota, ethanol, chlorhexidine
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Universidade do Vale do SapucaiUniversity, hospital or other
Study start: 30 May 2016 (actual)
Primary completion: 6 Jan 2017 (actual)
Study completion: 30 Jan 2017 (actual)
First posted: 14 Jul 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Alcohol group	Experimental	Other: alcohol antisepsisPatients allocated to this group will receive skin antisepsis with alcohol 70% prior spinal anesthesia
Chlorhexidine group	Experimental	Other: chlorhexidine antisepsisPatients allocated to this group will receive skin antisepsis with alcoholic solution of chlorhexidine 0.5% prior spinal anesthesia

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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 ;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
alcohol antisepsis	Other	Alcohol group
chlorhexidine antisepsis	Other	Chlorhexidine group

Primary outcome

Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)
Time frame: Before antisepsis
The material will be collected in a pre determined field of 25 cm², with a swab, and the maximum seeding in 8 hours, 48 hours after will be counted the number of colonies forming units per square centimeter (CFU/cm²)
Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)
Time frame: 2 minutes after antisepsis
The material will be collected in a pre determined field of 25 cm², with a swab, and the maximum seeding in 8 hours, 48 hours after will be counted the number of colonies forming units per square centimeter (CFU/cm²)
Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)
Time frame: After the Puncture and at most 40 minutes
The material will be collected in a pre determined field of 25 cm², with a swab, and the maximum seeding in 8 hours, 48 hours after will be counted the number of colonies forming units per square centimeter (CFU/cm²)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
Derived from this study: PubMed 33470369Tostes 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.
Individual participant dataSharing planned: No

Related trials for Anesthesia, Spinal

Recruiting
Patient-controlled Remimazolam Sedation Under Spinal Anesthesia
Hip Arthroplasty, Spinal Anesthesia
Not yet recruitingPhase 4
Two Doses of IV Magnesium Sulfate for Prevention of Post-Spinal Shivering
Post Spinal Anesthesia Shivering
RecruitingPhase 4
Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
Active, not recruiting
Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery
Maternal Hypotension After Spinal Anesthesia
Not yet recruitingPhase 4
Effects of Ondansetron Timing During Spinal Anesthesia for Urologic Surgery
Spinal Anesthesia-Induced Hypotension, Cerebral Oxygenation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniela F Veiga, MD, PhD study chair

Universidade do Vale do Sapucai

Ana Beatriz A Loyola, PhD study director

Universidade do Vale do Sapucai

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing alcohol antisepsis and chlorhexidine antisepsis in people with Anesthesia, Spinal and Anesthesia, Epidural, run by Universidade do Vale do Sapucai at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²) (time frame: Before antisepsis). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02833376, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017; AzTrials last refreshed its copy on 6 Nov 2026.