NCT Number: NCT07465887
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.
Trial opening soon.
Get Notified18 year–85 year
All sexes
Interventional
Not applicable
This study is a prospective, double-blind, randomized controlled trial evaluating the analgesic efficacy of two regional anesthesia techniques for patients undergoing elective 3-port Video-Assisted Thoracoscopic Surgery (VATS).
Procedure and Technique Following the induction of general anesthesia, participants are randomized (1:1) to receive either a Rhomboid-Intercostal Block (RIB) or a Thoracic Paravertebral Block (PVB) under ultrasound guidance.
Rhomboid-Intercostal Block (RIB): An injection of 30 ml of 0.375% Ropivacaine is administered in the plane between the rhomboid major and intercostal muscles at the T5 level.
Thoracic Paravertebral Block (PVB): An injection of 30 ml of 0.375% Ropivacaine is administered into the thoracic paravertebral space at the T5 and T7 levels.
Postoperative Clinical Management Pain intensity is monitored postoperatively. If a participant reports a Numerical Rating Scale (NRS) score greater than 4, a rescue analgesia protocol is initiated. This protocol consists of a bolus of intravenous (IV) Morphine (0.5 mg/kg). The investigators re-evaluate the NRS score after 20 minutes; if the score remains above 4, the dose is repeated. The investigators also monitor participants for potential complications, including hypotension, respiratory depression, and nausea/vomiting, throughout the 24-hour postoperative period.
Statistical Analysis Plan Pain scores across time points will be analyzed using a mixed-effects model or repeated measures ANOVA. Categorical data will be compared using the Chi-square test (χ^2). For continuous data, the distribution will be verified via the Kolmogorov-Smirnov test before applying the Student's t-test or the Wilcoxon signed-rank test as appropriate.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This 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
This 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 and T7 levels to provide postoperative analgesia
Time frame: Up to 24 hours after extubation
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.
Time frame: 24 hours post-surgery
Total consumption of morphine (in mg) administered as rescue analgesia over the 24-hour postoperative period
Time frame: 24 hours post-surgery
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 frame: From extubation up to 24 hours post-surgery
The time elapsed from the end of the surgery (extubation) until the first request for IV morphine rescue analgesia.
Contact information is provided by the study sponsor or research team.
Georgios Kotsovolis
Other
Comparison of the Ultrasound-Guided Rhomboid-Intercostal Block (RIB) Versus Thoracic Paravertebral Block (PVB) for Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery (VATS): A Double-Blind Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07653932
Central Sensitization, Chronic Postsurgical Pain
Wuhan, Hubei, China
View Trial DetailsNCT07387484
Neurologic Manifestations, Pain
View Trial DetailsNCT07655336
Neurologic Manifestations, Pain
Bursa, Nilüfer, Turkey (Türkiye)
View Trial DetailsNCT07610408
Acute Pain, Neurologic Manifestations
Ankara, Keçiören, Turkey (Türkiye)
View Trial Details