Surgical Oncology
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical trial. A total of 80 people who meet the eligibility criteria will be probabilistically allocated to one or another intervention group u
D26.660
V03.175.250
Sponsors
Faculdade de Medicina de Jundiaí
Hospital Universitário de Jundiaí
Eligibility
Sex/Gender
Female
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: They will integrate 80 patients aged between 20 and 65 years and physical status ASA I or II, who will undergo elective breast cancer surgeries, performed at the University Hospital of the Faculty of Medicine of Jundiaí (Jundiaí-SP).
Exclusion criteria
Exclusion criteria: Patient refusal; altered level of consciousness or inability to communicate; presence of any contraindication to the use of any agent described in the project; history of seizure disorder; currently using pregabalin or gabapentin; presence of chronic pain or use of opioids; body mass index (BMI) >40 kg/m2; insulin-dependent diabetes mellitus and renal failure (estimated glomerular filtration rate less than 60 ml/min/1.73 m²); violation of the protocol (such as the use of agents not described in the study protocol); refusal to respond to the questionnaire (QoR-15) in the perioperative period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find an improvement in the quality of anesthetic recovery in patients undergoing breast cancer surgery, with the preoperative use of Pregabalin. After collecting the data, the distribution of results will be verified by the Kolmogorov-Smirnov test, to test whether the hypotheses will present a normal distribution. If data are normally distributed, they will be presented as mean (SD-standard deviation) and evaluated by Student's t test. Data without normal and ordinal distribution will be reported as median (IRQ-interquartile range) and evaluated using the Mann-Whitney test. Categorical variables will be presented as percentages and evaluated using Fisher's test. The correlation between opioid consumption and overall postoperative recovery (assessed using the QoR-15) will be performed using Spearman's coefficient. The criterion for rejecting the null hypothesis will be a p<0.05 value for the primary outcome (QoR-15 comparison between groups). | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe a lower total opioid consumption, incidence of nausea and vomiting, length of stay in the post-anesthesia care unit, postoperative pain (evaluated every 15 minutes during the PACU stay) and pain in the ward (4 , 8, 12 hours after surgery and 24/48 hours by telephone, since, in general, patients will already be discharged from the hospital and the length of hospital stay). For secondary outcomes, a value of p<0.05 will also be used. A test power of 90% will be considered. Statistical analysis will be performed using the R Project for Statistical Computing software, version 3.3.1 (Copyright (C) 1989, 1991 Free Software Foundation, Inc.). | — |
Countries
Brazil
Contacts
Public ContactFábio Toledo
Hospital universitário de Jundiaí
Outcome results
None listed