Acute postoperative pain
Conditions
Interventions
30 patients undergoing bariatric surgery will receive pregabalin capsule 75mg ( single dose) orally one hour before surgery . ( Intervention group )
Patients in the control group ( 30 patients ) will
after reading and signing the Statement of Consent Free and Informed - consent form (Appendix 2) , applied by a member of the research team .
All patients will be randomized at random and will be moni
Drug
Sponsors
Unesp
Hospital Teresa De Lisieux
Hapvida Assistencia Medica Ltda
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients undergoing open bariatric surgery;Age: 18 to 64anos;Sex female and male;ASA : P1 ; P2 ; P3
Exclusion criteria
Exclusion criteria: History of allergy to pregabalin; Kidney disease; liver disease; Angle-closure glaucoma diagnosis; History of epilepsy; Patients using monoamine oxidase inhibitors or who have stopped use in the last 14 days.Patients illiterate; unable to sign the consent form. Chronic use of opioids and antidepressants;Allergy to NSAIDS and dipyrone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The expected primary outcome was assessed by the mean score obtained in the QoR 40 (Quality of Recovery 40) questionnaire composed of 40 questions - a total of 200 points, which is proposed to evaluate post anesthetic recovery quality, to be applied 24 hours after the surgery. 30 patients who received pregabalin 1 hour before the surgical procedure and 30 patients who received placebo were investigated.;Outcome found: no difference was found with statistical significance in the mean of points measured by the questionnaire used. The difference between the means was 2 points, (p = 0.6); Using Student's t-Test. | — |
Secondary
| Measure | Time frame |
|---|---|
| The expected secondary outcomes evaluated were: 1- Reduction of total morphine consumption (in milligrams) in the immediate postoperative period, first hour and in the 24 hours after surgery. 2-Residency time in the post anesthetic recovery room (RPA), in minutes, comparison of means. 3- Incidence of postoperative nausea and vomiting (PONV) in both groups, using Fisher's exact test 4- We analyzed the pain scores through the visual numerical scale of Pain (values from 0 to 10, being higher values related to more intense pain) at the moments 1 hour post surgery and 24 hours later.;Morphine consumption: For this question, the Mann Whitney test was used to compare the medians between the placebo and intervention groups and again there was no difference with statistical significance between the groups (p = 0.8) Length of stay in RPA: We did not show differences between groups, with statistical significance (p = 0.9) Outcome found for PONV: We did not identify statistical difference between the groups (p = 0.6). Pain scores, outcome found: No differences were identified with p <0.05. Thus, we concluded that the intervention using pregabalin at the dose used and in the surgery model did not offer a significant improvement in the quality of post anesthetic recovery. | — |
Countries
Brazil
Contacts
Public ContactMarcelo Martins
Unesp
Outcome results
None listed