- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465887
Ultrasound-Guided Rhomboid-Intercostal Block Versus Thoracic Paravertebral Block for VATS Analgesia
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
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dimitra Katholiki Papazoglou
- Phone Number: 00306983150795
- Email: dimitapaz22@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (18-85 years old),
- ASA physical status I-III
- scheduled for elective 3-port unilateral VATS.
Exclusion Criteria:
- Allergy to local anesthetics
- infection at the injection site
- coagulation disorders
- severe neurological disorder
- obesity (BMI > 35)
- opioid addiction
- conversion to open thoracotomy, admission to ICU.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ultrasound-Guided Rhomboid-Intercostal Block (RIB)
|
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
|
|
Active Comparator: Ultrasound-Guided Thoracic Paravertebral Block (PVB)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Intensity
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.
|
Up to 24 hours after extubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Opioid Consumption
Time Frame: 24 hours post-surgery
|
Total consumption of morphine (in mg) administered as rescue analgesia over the 24-hour postoperative period
|
24 hours post-surgery
|
|
Incidence of Complications
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.
|
24 hours post-surgery
|
|
Time to First Request for Rescue Analgesia
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.
|
From extubation up to 24 hours post-surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIB-PVB-VATS-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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