Ivanildo Archangelo Jr
Pouso Alegre, Minas Gerais, 37550-000, Brazil
NCT Number: NCT02257255
Cesarean section is the most performed abdominal surgery in women, worldwide. The World Health Organization (WHO) considers 15% of deliveries the ideal rate of this surgery. However, Brazil presents the highest rates of cesarian section in the world, reaching 85% in hospitals and private clinics.
The most used technique of cesarean section is the known as Pfannenstiel or Classical technique. In 1996, a new technique was described, called Misgav Ladach or minimally invasive technique.
Several studies have show that the minimally invasive technique is faster and promotes lower costs and less intraoperative bleeding. There is no current evidence that this technique is less painful.
This study aims to compare the postoperative pain in both techniques,by means of two pain scales: a one-dimensional scale, the Visual Analogue Scale, and a multidimensional scale, the McGill Scale.
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Interventional
Not applicable
Pouso Alegre, Minas Gerais, 37550-000, Brazil
Primary, clinical, prospective, randomized, double blind with, controlled, two parallel groups interventional and analytical.
A-CALCULATION OF SAMPLE SIZE
Were used to calculate the size of the sample study data Antalon et al. (2001), who also compared the two techniques of caesarean section, and the Student's t-test was used bi flow. Considering a standard deviation of 1.5 points in the Visual Analog Pain Scale, and significant a difference of two points, the calculated number of patients per group was 15, with a significance level of 5% and power of 95 test %.
C RANDOMIZATION AND CONFIDENTIALITY OF ALLOCATION
The allocation will be determined by random sequence generated by computer (BioStat 5.0 software, Mamiraua Institute, Brazil). The sequence had been held by the researcher who will make allocation of patients to groups in caesarean Pfannenstiel or Misgav-Ladach, 15 in each group.
D-PROCEDURES
ANESTHESIA:
In both groups will be performed spinal anesthesia at L2-L4 with heavy bupivacaine 13 mg and morphine 0.1 mg% standardized by the Anesthesiology Service of HCSL.
SURGICAL PROCEDURE:
Surgical procedure (classical technique)
Once displayed, according to the behavior of the service, this will be performed according to the following surgical technique:
Surgery (minimally invasive technique)
Once displayed, according to the behavior of the service, this will be performed according to the following surgical technique:
F-STATISTICAL METHOD The data will be tabulated and subjected to statistical analysis. The level of rejection of the null hypothesis will be set at 5% (α <0.05).
For numeric variables will be used descriptive statistics, with calculations of median, mean and deviation padrão.O Mann-Whitney test is used to compare two independent groups with nonparametric behavior and the chi-square test for categorical variables.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pain scales ( VAS and McGill ) 6, 12 and 24 hours after cesarean to pain assessment
Pain scales (VAS and McGill) 6, 12 and 24 hours ater cesarean to pain assessment
Time frame: Postoperative 24 hours
pain assessment using two kinds of pain scales VAS and McGILL scale at 6, 12 and 24 hours of postoperative
Time frame: 1 hour
compare time spent in each technique, considering only cesarean that spent less than 1 hour
Universidade do Vale do Sapucai
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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