Analgesia. Cesarean Section
Conditions
Interventions
Intervention group: 31 women undergoing cesarean section will receive a lidocaine patch on the margins of the operative wound at times 0, 12 and 24 hours after surgery. Control group: 31 women undergo
Drug
HP3.073.433.101
Sponsors
Universidade Estadual Paulista "Júlio de Mesquita Filho"
Instituto de Saúde Elpídio de Almeida - ISEA
Universidade Estadual Paulista "Júlio de Mesquita Filho"
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age equal or superior to 18 years; Being submitted to cesarean section under spinal anesthesia; Classification of the American Society of Anesthesiologists 1 or 2.
Exclusion criteria
Exclusion criteria: Patients with a history of intolerance or chronic use of opioids or other medications proposed in the anesthetic procedure; Patients requiring tracheal intubation or supraglottic device during cesarean section; Patients who need to perform other surgical procedures concomitantly; Alcohol or drug addicts; Use of analgesics, opioids or not, within 24 hours prior to the procedure; Patients who report chronic pain in a previous cesarean operative wound; Inability to provide informed consent and low easily identifiable cognition; Patients with contraindication to neuroaxis blockade.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute pain relief in the postoperative period of cesarean section with decreased levels of pain assessed by the Digital Verbal Scale (NVE) of pain in the periods of 10, 20, 30, 40, 50, 60 minutes and 6, 12, 24 and 36 hours after surgery with a pain scale score lower than 4 in the lidocaine group compared with values greater than 5 in the control group | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 1: decrease in the need for complementary doses of analgesics in the postoperative period evaluated by means of medical record in the periods of 10, 20, 30, 40, 50, 60 minutes and 6, 12, 24 and 36 hours after surgery demonstrating the use of lower doses by patients in the lidocaine group when compared with placebo;Expected outcome 2: Improvement in the level of patient satisfaction assessed through the Quality of Recovery-40 (QoR-40) scale with patients in the lidocaine group presenting a higher score regarding the satisfaction of the surgical recovery with values close to 200 when compared to the placebo group who may present values below 150 | — |
Countries
Brazil
Contacts
Public ContactVaniely de Queiroz
Universidade Estadual Paulista "Júlio de Mesquita Filho"
Outcome results
None listed