Comparison of Paravertebral Versus Epidural Block for Post-thoracotomy Pain Control (NCT07763249) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Paravertebral Versus Epidural Block for Post-thoracotomy Pain Control
Brazil80 participantsStarted 2026-09-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 18 years or older;
* Elective thoracic surgeries requiring open thoracotomy;
* American Society of Anesthesiologists (ASA) physical status I to III.
Exclusion Criteria:
* Pregnancy or lactation;
* Urgent or emergency surgeries;
* Contraindications to epidural catheter insertion or neuraxial anesthesia;
* Infection at the proposed block site;
* Patient refusal to undergo the study blocks;
* Video-assisted thoracic surgeries;
* Anticipated need for invasive mechanical ventilation in the postoperative period;
* Chronic opioid use (daily use for more than 3 months of ≥10 mg oral morphine equivalent);
* Severe vertebral deformities or previous thoracic spine surgery that prevent safe performance of the blocks;
* Known allergy to local anesthetics, opioids, or study medications;
* Body mass index \> 35 kg/m²;
* Advanced liver or kidney failure (Child-Pugh C or estimated glomerular filtration rate \< 50 mL/min/1.73 m²);
* Severe cognitive impairment that prevents understanding of instructions or pain assessment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean pain intensity at rest during the first 48 hours after surgery