caesarean
Conditions
Interventions
Patients submitted to elective cesarean from June 2019 to December 2019 will be randomized into 2 groups: spinal anesthesia with morphine and spinal anesthesia without morphine associated with lumbar
Procedure/surgery
Sponsors
Universidade Federal de São Paulo
Universidade Federal de São Paulo
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: The inclusion criteria will be: ASA I and ASA II patients; with gestational age of at least 37 weeks; normal and single gestation,age between 18 and 60 years.
Exclusion criteria
Exclusion criteria: Os critérios de exclusão serão: inabilidade de compreender ou verbalizar a escala de avaliação da dor; coagulopatias congênitas; anormalidades anatômicas e infecção localizada.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find superior efficacy in promoting postoperative pain relief in cesarean sections, in the Lumbar Quadricep Block in comparison with intrathecal Morphine. The expected outcome will be verified by the following statistical methods described below. Statistical analyzes will be performed using IBM SPSS Statistics version 22 software. The normality of the quantitative variables will be verified through the Kolmogorov-Smirnov test or the Shapiro-Wilk test. Quantitative variables that present normal (Gaussian) distribution will be represented by means, standard deviation and number of valid observations (n). Quantitative variables that do not present normal distribution will be represented by median, interquartile range and number of valid observations. Qualitative variables will be represented by simple frequency and percentage. Student's t-test will be used to compare groups in relation to quantitative variables with Gaussian distribution and the non-parametric Mann-Whitney test will be used to compare groups in relation to quantitative variables without Gaussian distribution. The Chi-square test (or Fisher's Exact or Likelihood Ratio) will be used to compare groups in relation to qualitative variables. The variance analysis model (ANOVA) with repeated measures will be used to compare the quantitative variables with gaussian distribution over time after surgery (1h, 2h, 4h, 6h, 12h, 24h and 48h). In the case of quantitative variables that do not present a Gaussian distribution, the comparison over time after surgery will be performed using the non-parametric Friedman test. The Cochran test will be used to compare qualitative variables over time after surgery (1h, 2h, 4h, 6h, 12h, 24h and 48h). The level of significance used in all comparisons will be 5% (p-value less than 0.05 will represent a difference with statistical significance). | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that there will be no significant difference between groups in heart rate. The expected outcome will be verified by the following statistical methods described below. The normality of the quantitative variables will be verified through the Kolmogorov-Smirnov test or the Shapiro-Wilk test. Quantitative variables that present normal (Gaussian) distribution will be represented by means, standard deviation and number of valid observations (n). Quantitative variables that do not present normal distribution will be represented by median, interquartile range and number of valid observations. The level of significance used in all comparisons will be 5% (p-value less than 0.05 will represent a difference with statistical significance).;It is expected that there is no significant difference between the groups regarding respiratory rate. The expected outcome will be verified by the following statistical methods described below. The normality of the quantitative variables will be verified through the Kolmogorov-Smirnov test or the Shapiro-Wilk test. Quantitative variables that present normal (Gaussian) distribution will be represented by means, standard deviation and number of valid observations (n). Quantitative variables that do not present normal distribution will be represented by median, interquartile range and number of valid observations. The level of significance used in all comparisons will be 5% (p-value less than 0.05 will represent a difference with statistical significance).;It is expected that there will be no significant difference between groups regarding oxygen saturation. The expected outcome will be verified by the following statistical methods described below. The normality of the quantitative variables will be verified through the Kolmogorov-Smirnov test or the Shapiro-Wilk test. Quantitative variables that present normal (Gaussian) distribution will be represented by means, standard deviation and number of valid observations (n) | — |
Countries
Brazil
Contacts
Public ContactKaroline de Araújo
Universidade Federal de São Paulo
Outcome results
None listed