Postoperative PainNCT07465887
Ultrasound-Guided Rhomboid-Intercostal Block Versus Thoracic Paravertebral Block for VATS Analgesia
A study testing Ultrasound-Guided Rhomboid-Intercostal Block (RIB) and Ultrasound-Guided Thoracic Paravertebral Block (PVB) in people with Postoperative Pain and Thoracic Surgery, run by Georgios Kotsovolis at 1 site in Greece.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain, Thoracic Surgery, Thoracic Surgery, Video Assisted
- What is being tested?
- Ultrasound-Guided Rhomboid-Intercostal Block (RIB) and Ultrasound-Guided Thoracic Paravertebral Block (PVB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 9 Mar 2026to Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18-85 years old),
- ASA physical status I-III
- scheduled for elective 3-port unilateral VATS.
Who cannot join
- 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.
- renal disease, high serum Creatinine levels
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Blue Cross Thessaloniki
Thessaloniki
Georgios Kotsovolis, PhD, +306948182743, gskotsos@gmail.com
About this study
Official title: 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).
Read more
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.
Read the 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 level.
Postoperative Clinical Management Each patient, before extubation, receives intravenously 0.5 mg/kg morphine , 1g paracetamol 40mg parecoxib and 8mg ondansetron.
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.
- Conditions
- Postoperative Pain, Thoracic Surgery, Thoracic Surgery, Video Assisted, Ultrasound Guided, Paravertebral Thoracic Block, Rhomboid Intercostal Block
- Being tested
- Ultrasound-Guided Rhomboid-Intercostal Block (RIB), Ultrasound-Guided Thoracic Paravertebral Block (PVB)
- Keywords
- VATS, Rhomboid-intercostal Block, Paravertebral Thoracic Block, Regional Anesthesia, Postoperative Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Rhomboid-Intercostal Block (RIB)Procedure or surgery
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
Ultrasound-Guided Thoracic Paravertebral Block (PVB)Procedure or surgery
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 level to provide postoperative analgesia
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Rhomboid-Intercostal Block (RIB) | Experimental | Not described Receives: Procedure: Ultrasound-Guided Rhomboid-Intercostal Block (RIB) |
| Ultrasound-Guided Thoracic Paravertebral Block (PVB) | Active comparator | Not described Receives: Procedure: Ultrasound-Guided Thoracic Paravertebral Block (PVB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 hours after extubation
Secondary outcomes (3)
Total Opioid Consumption
Total consumption of morphine (in mg) administered as rescue analgesia over the 24-hour postoperative period
Measured: 24 hours post-surgery
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.
Measured: 24 hours post-surgery
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.
Measured: From extubation up to 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start9 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgios Kotsovolis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Georgios Kotsovolis, Blue Cross of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465887
- Sponsor's protocol ID
- RIB-PVB-VATS-2026
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD collected throughout the trial, only IPD used in the results publication