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Completed

NCT Number: NCT04579276

Different Approaches to Thoracic Paravertebral Block

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).

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Key information

Conditions

Thoracotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

assistance publique hôpitaux de Marseille

Marseille, 13354, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thoracic Paravertebral Block

Procedure

Intrathoracic method undergone through video assisted surgery (VATS

Thoracic epidural analgesia

Procedure

locoregional analgesia under ultrasound control

Primary outcomes

  1. total morphine consumption

    Time frame: 48 HOURS

Secondary outcomes

  1. Time occupancy of the operating room

    Time frame: 1 MONTH

  2. visual analog scale of pain (VAS)

    Time frame: 12 HOURS

  3. visual analog scale of pain (VAS)

    Time frame: 48HOURS

  4. visual analog scale of pain (VAS)

    Time frame: 30 DAYS

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: VAP BLOCK

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2020
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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