About this trial
Purpose of the study The goal of this research is to see which of two nerve-numbing techniques-the Rhomboid-Intercostal Block (RIB) or the Thoracic Paravertebral Block (PVB)-works better to control pain after chest surgery (specifically, video-assisted thoracoscopic surgery, or VATS). Both techniques use numbing medication to block pain signals after the operation.
Who can participate? The researchers are looking for adults between 18 and 85 years old who are scheduled for a specific type of chest surgery (a 3-port VATS procedure).
How will the research happen? Participants will be put into two equal groups by chance. One group will receive the RIB technique, and the other group will receive the PVB technique. Both procedures are done under ultrasound guidance after the completion of surgery, while the patient is still asleep. The pain levels of the participants will be measured at rest and when taking deep breaths at several times during the first 24 hours after surgery.
Why is this study useful? This study aims to find out which pain relief method is more effective and if one results in fewer side effects, such as nausea or the need for stronger pain medications (opioids). These results will possibly help doctors provide better comfort to patients recovering from chest surgery in the future.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (18-85 years old),
ASA physical status I-III
scheduled for elective 3-port unilateral VATS.
Disqualifiers
Allergy to local anesthetics
infection at the injection site
coagulation disorders
severe neurological disorder
Trial design
Parallel
Treatments tested in this trial
Ultrasound-Guided Rhomboid-Intercostal Block (RIB)
Procedure/SurgeryThis is an ultrasound-guided regional anesthesia procedure performed after the completion of the operation, while the patient is still asleep. A dose of 30 ml of 0.375% Ropivacaine is injected into the plane located between the rhomboid major and the intercostal muscles at the T5 level to provide postoperative analgesia
Ultrasound-Guided Thoracic Paravertebral Block (PVB)
Procedure/SurgeryThis is an ultrasound-guided regional anesthesia procedure performed after the completion of the operation, while the patient is still asleep. A dose of 30 ml of 0.375% Ropivacaine is injected into the thoracic paravertebral space at the T5 level to provide postoperative analgesia
Treatment groups
Trial outcomes
Primary outcomes
Postoperative Pain Intensity
Pain intensity will be measured 1, 2, 6, 12, and 24 hours after extubation using the Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain) . Measurements will be recorded at rest and during deep inspiration.
Secondary outcomes
Total Opioid Consumption
Total consumption of morphine (in mg) administered as rescue analgesia over the 24-hour postoperative period
Incidence of Complications
Incidence of specific complications including hematoma (significant ecchymosis or edema at entry site) , hypotension (MAP \< 65 mmHg or \>20% drop from baseline) , respiratory depression (rate \< 10 breaths/min) , and postoperative nausea/vomiting.
Time to First Request for Rescue Analgesia
The time elapsed from the end of the surgery (extubation) until the first request for IV morphine rescue analgesia.
Sponsors and contacts
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Georgios Kotsovolis
Lead sponsor
Blue Cross of Thessaloniki
Sponsor institution