NCT07465887

Brief 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). 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 Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
9mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

March 6, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

March 6, 2026

Last Update Submit

March 18, 2026

Conditions

Keywords

VATSRhomboid-intercostal BlockParavertebral Thoracic BlockRegional AnesthesiaPostoperative Analgesia

Outcome Measures

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.

    Up to 24 hours after extubation

Secondary Outcomes (3)

  • Total Opioid Consumption

    24 hours post-surgery

  • Incidence of Complications

    24 hours post-surgery

  • Time to First Request for Rescue Analgesia

    From extubation up to 24 hours post-surgery

Study Arms (2)

Ultrasound-Guided Rhomboid-Intercostal Block (RIB)

EXPERIMENTAL
Procedure: Ultrasound-Guided Rhomboid-Intercostal Block (RIB)

Ultrasound-Guided Thoracic Paravertebral Block (PVB)

ACTIVE COMPARATOR
Procedure: Ultrasound-Guided Thoracic Paravertebral Block (PVB)

Interventions

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 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 thoracic paravertebral space at the T5 and T7 levels to provide postoperative analgesia

Ultrasound-Guided Thoracic Paravertebral Block (PVB)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (18-85 years old),
  • ASA physical status I-III
  • scheduled for elective 3-port unilateral VATS.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Dimitra Katholiki Papazoglou

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Kotsovolis Georgios, MD, Msc, PhD

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 12, 2026

Study Start

March 9, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

all IPD collected throughout the trial, only IPD used in the results publication

Shared Documents
STUDY PROTOCOL, SAP, ICF