Ultrasound-Guided Rhomboid-Intercostal Block Versus Thoracic Paravertebral Block for VATS Analgesia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorGeorgios Kotsovolis

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-Guided Rhomboid-Intercostal Block (RIB)

    Procedure/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/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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Ultrasound-Guided Rhomboid-Intercostal Block (RIB)Experimental treatment 1 intervention
Group B: Ultrasound-Guided Thoracic Paravertebral Block (PVB)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 24 hours after extubation

Secondary outcomes

1

Total Opioid Consumption

Total consumption of morphine (in mg) administered as rescue analgesia over the 24-hour postoperative period

Time frame
24 hours post-surgery
2

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 frame
24 hours post-surgery
3

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.

Time frame
From extubation up to 24 hours post-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Georgios Kotsovolis

Lead sponsor

Blue Cross of Thessaloniki

Sponsor institution