Chronic pain Thoracic Surgery
Conditions
Interventions
This is a two-arm randomized controlled clinical trial that will include a total of 60 participants, randomly allocated in a 1:1 ratio into two groups, with 30 participants assigned to the experimenta
no masking (blinding) will be applied, characterizing the study as open-label, as both the healthcare professionals performing the intervention and the participants will be aware of group allocation d
participants in the experimental group will undergo an ultrasound-guided bilateral parasternal block performed at the T3–T4 intercostal level using a 20-gauge needle, with administration of 20 millili
participants in the control group will receive only the same multimodal analgesia protocol without the parasternal block
all participants will undergo standardized anesthetic induction and maintenance according to institutional protocol, including administration of midazolam, ketamine, etomidate, fentanyl, remifentanil,
Sponsors
Fundação Paraibana de Gestão em Saúde - PB Saúde.
Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients of both sexes who will undergo cardiac surgery; age between 18 and 80 years
Exclusion criteria
Exclusion criteria: Patients with puncture site infection; patients with systemic infection or hemodynamic instability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the incidence and intensity of chronic postoperative pain in patients undergoing cardiac surgery, by applying the Numerical Verbal Pain Scale at standardized times (immediately after extubation, at 2 hours, 12 hours and 24 hours) and by telephone contact after 12 weeks, when the Douleur Neuropathique en 4 Questions questionnaire will also be applied to assess neuropathic pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include the assessment of intraoperative hemodynamic parameters, immediate postoperative pain intensity, opioid consumption in the first 24 hours, and the presence of neuropathic pain after 12 weeks; outcome verification will be performed using the Numerical Verbal Pain Scale at standardized times (immediately after extubation, at 2 hours, 12 hours, and 24 hours) and by telephone contact after 12 weeks, when the Douleur Neuropathique en 4 Questions questionnaire will also be applied to assess neuropathic pain; additionally, hemodynamic parameters such as systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate will be monitored during the intraoperative period, as well as opioid consumption during the intra- and postoperative periods, including the need for rescue doses, allowing for quantitative and comparative analysis between the groups. | — |
Countries
BR
Contacts
Public ContactRodrigo Miranda
Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed