Thoracic pain, unspecified
Conditions
Interventions
This is a two-arm, blinded, randomized controlled clinical trial. A total of 240 patients will be allocated into two intervention groups: Group A and Group B. Group A will receive an Erector spinae pl
Sponsors
Instituto de Assistência Médica ao Servidor Público Estadual de São Paulo
Faculdade de Medicina da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients over 18 years of age undergoing unilateral pulmonary surgery under thoracotomy or thoracoscopy approach
Exclusion criteria
Exclusion criteria: Patients who refuse participation. Severe puncture site infection or deformity. Coagulation disorder (International normalized ratio greater than 1.4 or use of anticoagulant medications and platelet count less than 100,000 / mm3). Body mass index greater than 35kg / m2. Renal impairment (creatinine clearance less than 30 ml / min). Failure to operate the Patient Controlled Analgesia system (PCA) or to sign the informed consent form. Patients undergoing bilateral surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Assess pain measured by the numerical rating scale (NRS) at 24 hours after surgery, with an overall test of the interaction of all measures and appropriate multiplicity Bonferroni adjustment and considering a 10 percent difference as a non-inferiority margin. Postoperative pain measurements occurred at 3 time points: at admission to a pregnancy recovery room, at the time of discharge after surgery, and on the first postoperative day of recovery, 24 hours after the surgical procedure. ;Outcome found 1: Pain measurements using NRS showed that ESPB arm had higher overall pain scores (GLM, P equal to 0.02), major influenced by the measurements at admission to the PACU (7.6 more or less 1.3 in the ESPB group versus 5.9 more or less 2.5 in the PVB group, difference minus 1.7 (minus 22.4 percent), 95 percent CI minus 2.4 to minus 0.90, P less than 0.001) and at discharge from the PACU (4.6 more or less 2.4 in the ESPB group versus 3.6 more or less 2.5 in the PVB group, difference minus 0.99 (-21.7 percent), 95 percent CI minus 1.9 to minus 0.1, P equal to 0.04). However, the ESPB group had pain scores lower than the PVB group after 24 hours (1.5 more or less 2.4 in the ESPB group versus 2.1 more or less 2.2 in the PVB group, difference 0.36 ( plus 40,0 percent), 95 percent CI minus 0.5 to 1.2, P equal to 0.19). Postoperative failure of analgesia was higher in the ESPB when compared to PVB using NRS, 65 per 183 vs. 40 per 177 measures, respectively; RR 1.57 (95 percent CI 3.6, 22.2; P equal to 0.008). | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome found 2: We observed that the intervention of the BPV group was evaluated as being significantly more technically difficult to perform than the BPE in both aspects, both for the block (difficulty level = 4, IQR = 2-5 in the BPE group versus difficulty level = 7, IQR = 5.75-8 in the BPV group; P < 0.001) and for catheter placement (difficulty level = 3, IQR = 2-4 in the BPE group versus difficulty level = 7, IQR = 6-8 in the BPV group; P < 0.001.;Outcome found 3: pain measurements using the Wong-Baker faces scale also showed higher pain scores in the BPE group at the times of admission to RPA (P = 0.002) and at discharge from RPA (P = 0.04), but it was not found significant difference in the assessment 24 hours after the end of the surgical procedure (P = 0.0641);Outcome found 4: Despite the differences in pain and opioid consumption, there was no significant difference in patient satisfaction at any time over 24 hours (GLM, P = 0.863) ;Outcome found 5: The ESPB arm presented higher postoperative consumption of morphine than the PVB arm in all measurements over the first 24 hours after surgery (GLM, P = 0.01), with statistically significant differences at admission to the PACU (1.7±0.8 mg in the ESPB group versus 1.1±1.0 mg in the PVB group, difference -0.6, 95%CI: -0.9 a -0.2, P = 0.003), at discharge from the PACU (7.4±3.5 mg in the ESPB group versus 5.9±3.5 mg in the PVB group, difference -1.3, 95%CI: -2.5 a -0.02, P = 0.03), and 24 hours after surgery (19.9±10.2 mg in the ESPB group versus 15.5±10.1 mg in the PVB group, difference -3.7, 95%CI: -7.5 to -0.05, P = 0.03);Outcome found 8: The overall analysis of pain using VDS corroborated the differences in analgesia failure indicated by other pain assessment scales. (P = 0,03);Expected outcome 2: Evaluate the degree of difficulty in performing the regional anesthesia technique, quantified by a score of 0 to 10 determined by the physician who performed the block.;Expected outcome 3: Pain assessment through t | — |
Countries
Brazil
Contacts
Public ContactPedro Hilton Andrade Filho
Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed