Different Approaches to Thoracic Paravertebral Block (VAP BLOCK)

May 4, 2026 updated by: Assistance Publique Hopitaux De Marseille

Different Approaches to Thoracic Paravertebral Block: a Monocentric Randomized Study Comparing Ultrasounded-guided Method to Intrathoracic Visual Method

Thoracic paravertebral block (TPB) in thoracic surgery is practiced since the development of minimally invasive surgery. Historically, thoracic epidural analgesia is done in open thoracic surgery. Thoracotomy with rib spacing causes strong post-operative pain that is well controlled with epidural analgesia and allows less use of morphine. However, this method causes frequent side effects. Minimally invasive surgery, when it is possible and recommended, has the main benefit of not spacing the ribs and therefore preventing nerve stretching, rib fractures and less post-operative pain. This less aggressive method has other benefits: less inflammation, better recuperation especially for vulnerable patients (the elderly; limited pulmonary functions), less time of thoracic drainage, less in hospital stay and better quality of life (1). Less invasive surgery has brought us to use less invasive analgesic methods. Thoracic paravertebral block is a good alternative to thoracic epidural analgesia but is unfortunately not done everywhere due to the lack and need of professional training. The objective of our study is to compare two methods of TPB: ultrasound guided method undergone by the anesthesiologist, and intrathoracic method undergone through video assisted surgery (VATS) or robotic assisted surgery (RATS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized prospective mono-centric non-inferiority controlled and simple blinded study comparing the "surgical" method (experimental group) to the "anesthetic" method (control group) for patients operated in thoracic minimally invasive surgery (VATS or RATS).

Recruitment: Patients undergoing therapeutic or diagnostic surgery in the thoracic ward of the university hospital of Marseille.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female ≥ 18 years of age.
  • VATS or RATS with lung resection including wedges, segmentectomies or lobectomies.
  • Signed consent.
  • Scheduled surgeries.

Exclusion Criteria:

  • Patient refusing to sign the consent form.
  • Minors.
  • Patients under any guardianship.
  • All surgeries with pleura intervention: talc, pleurectomy, wall resection.
  • Non trained anesthesiologist to ultrasound TPB.
  • Presence of pain or daily use of painkillers prior to surgery.
  • Medical history of homolateral thoracic surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "surgical" method
Procedure: Thoracic paravertebral block
Intrathoracic method undergone through video assisted surgery (VATS
Active Comparator: "anesthetic" method
Procedure: thoracic epidural analgesia
locoregional analgesia under ultrasound control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
total morphine consumption
Time Frame: 48 HOURS
48 HOURS

Secondary Outcome Measures

Outcome Measure
Time Frame
Time occupancy of the operating room
Time Frame: 1 MONTH
1 MONTH
visual analog scale of pain (VAS)
Time Frame: 12 HOURS
12 HOURS
visual analog scale of pain (VAS)
Time Frame: 48HOURS
48HOURS
visual analog scale of pain (VAS)
Time Frame: 30 DAYS
30 DAYS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Emilie GARRIDO- PRADALIE, Assistance Publique Hopitaux de Marseille
  • Principal Investigator: JOSEPHINE CHENESSEAU, Assistance Publique Hopitaux de Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2020

Primary Completion (Actual)

December 8, 2021

Study Completion (Actual)

December 8, 2021

Study Registration Dates

First Submitted

September 4, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-11
  • 2020-A00483-36 (Other Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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