Evaluation of different anesthetic techniques during the aesthetic application of botulinum toxin in the upper third of the face: randomized clinical trial

Evaluation of different Anesthetic Techniques in Orofacial harmonization procedures: randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-3t2rmfs

Enrollment

Unknown

Registered

2024-08-13

Start date

2023-01-06

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Interventions

Evaluation of the effectiveness of different anesthetic techniques during the cosmetic application of botulinum toxin in the upper third of the face through a Randomized Clinical Trial. Patient satisf

in the second part, preference and satisfaction with the anesthetic technique used

and in the third part, patients will be able to express the feelings and/or perceptions they may have about each anesthetic method used.

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Female patients, aged over 18 years, systemically healthy, with no previous history of botulinum toxin application in the upper third of the face and who presented dynamic wrinkles in the upper third of the face.

Exclusion criteria

Exclusion criteria: Patients with abusive use of alcohol or illicit drugs, moderate smokers (> 10 cigarettes/day), history of facial surgery, pregnant or breastfeeding, pre-existing disorders that affect neuromuscular function (such as myasthenia gravis, motor neurone disease), infections locals, undergoing remote or recent (< 2 years) laser, radiotherapy or chemotherapy treatment in the orofacial region, who continuously take medications that may affect the metabolism of inflammatory mediators, and who are hypersensitive or allergic to botulinum toxin.

Design outcomes

Primary

Measure	Time frame
Measure the level of pain discomfort caused by each anesthetic technique, using the Visual Analogue Scale (VAS) as a method in a pre-designed questionnaire. The results of each group will be evaluated using the Saphiro-Wilk test, in order to find normality in the distribution. After this, the paired sample t-test will be used for comparative analysis within each randomized group. A significance level of 5% will be adopted for all tests.;Verify preference and satisfaction with the anesthetic technique used, using a pre-designed questionnaire as a method. The results of each group will be evaluated using the Saphiro-Wilk test, in order to find normality in the distribution. After this, the Chi-square or Fisher's exact tests will be used to compare the distribution of frequencies within the randomized groups. A significance level of 5% will be adopted for all tests.;Check the feelings and/or perceptions that patients may have about each anesthetic method used, using a pre-designed questionnaire as a method. The results of each group will be evaluated using the Saphiro-Wilk test, in order to find normality in the distribution. After this, the Chi-square or Fisher's exact tests will be used to compare the distribution of frequencies within the randomized groups. A significance level of 5% will be adopted for all tests.	—

Measure

Time frame

Measure the level of pain discomfort caused by each anesthetic technique, using the Visual Analogue Scale (VAS) as a method in a pre-designed questionnaire. The results of each group will be evaluated using the Saphiro-Wilk test, in order to find normality in the distribution. After this, the paired sample t-test will be used for comparative analysis within each randomized group. A significance level of 5% will be adopted for all tests.;Verify preference and satisfaction with the anesthetic technique used, using a pre-designed questionnaire as a method. The results of each group will be evaluated using the Saphiro-Wilk test, in order to find normality in the distribution. After this, the Chi-square or Fisher's exact tests will be used to compare the distribution of frequencies within the randomized groups. A significance level of 5% will be adopted for all tests.;Check the feelings and/or perceptions that patients may have about each anesthetic method used, using a pre-designed questionnaire as a method. The results of each group will be evaluated using the Saphiro-Wilk test, in order to find normality in the distribution. After this, the Chi-square or Fisher's exact tests will be used to compare the distribution of frequencies within the randomized groups. A significance level of 5% will be adopted for all tests.

—

Secondary

Measure	Time frame
No secondary outcomes are expected.	—

Countries

Brazil

Contacts

Public ContactLetícia Gonçalves

Universidade Federal do Maranhão

leticia.goncalves@ufma.br+55(98)991020406

Outcome results

None listed

Source: REBEC (via WHO ICTRP)