This is a randomized, assessor-blinded, non-inferiority clinical trial comparing continuous thoracic paravertebral block (BPV) versus continuous thoracic epidural block (BPD) for postoperative pain control in adult patients undergoing elective open thoracotomy with one-lung ventilation. The primary outcome is the mean pain intensity at rest assessed by the Numeric Verbal Scale (NVS 0-10) during the first 48 hours after surgery. A total of 80 participants will be randomized 1:1 at Hospital de Clínicas de Porto Alegre, Brazil. The study aims to determine whether BPV provides non-inferior analgesia compared to BPD, with a potential advantage of less hemodynamic interference and better postoperative mobilization.
Patients aged 18 years or older;
Elective thoracic surgeries requiring open thoracotomy;
American Society of Anesthesiologists (ASA) physical status I to III.
Pregnancy or lactation;
Urgent or emergency surgeries;
Contraindications to epidural catheter insertion or neuraxial anesthesia;
Infection at the proposed block site;
Parallel
Continuous Thoracic Paravertebral Block
Procedure/SurgeryParticipants randomized to the continuous thoracic paravertebral block (BPV) group. At the end of surgery and before chest tube placement, a paravertebral catheter is inserted under direct thoracoscopic vision (without ultrasound) using a Tuohy needle. A bolus of ropivacaine 0.375% (15 mL, fractionated) is administered, followed by continuous infusion of bupivacaine 0.125% at 0.10 mL/kg/h. The target level is T5-T7 (or T5-T9). The catheter remains in place for at least 48 hours postoperatively.
Continuous Thoracic Epidural Block
Procedure/SurgeryParticipants randomized to the continuous thoracic epidural block (BPD) group. At the beginning of surgery, an epidural catheter is inserted at the thoracic level using the loss-of-resistance technique. A bolus of ropivacaine 0.375% (15 mL, fractionated) is administered, followed by continuous infusion of bupivacaine 0.125% at 0.10 mL/kg/h. The target level is T5-T7 (or T5-T9). The catheter remains in place for at least 48 hours postoperatively.
Mean pain intensity at rest during the first 48 hours after surgery
Mean of the pain scores at rest measured by the Numeric Verbal Scale (NVS 0-10) at 6, 12, 24, and 48 hours postoperatively. This composite measure is the primary endpoint for the non-inferiority comparison between continuous thoracic paravertebral block and continuous thoracic epidural block.
Pain on movement
Pain intensity during movement (e.g., coughing, sitting, or walking) assessed by Numeric Verbal Scale (0-10) at 6, 12, 24, and 48 hours postoperatively.
Total opioid consumption in the first 48 hours
Total opioid consumption (converted to intravenous morphine equivalents in mg) from the end of surgery until 48 hours postoperatively.
Block-related complications
Incidence of complications related to the regional blocks, including hypotension (systolic BP \< 100 mmHg or \>20% drop from baseline), urinary retention requiring catheterization, motor block (modified Bromage scale), and technical failure of the block.
Clinically significant pulmonary and cardiovascular complications
Incidence of clinically significant pulmonary complications (e.g., atelectasis requiring intervention, pneumonia) and cardiovascular complications (e.g., arrhythmias requiring treatment, ischemic events) in the first 72 hours after surgery.
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