Different Approaches to Thoracic Paravertebral Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2021-12-08

Brief Summary

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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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Detailed Description

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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.

Conditions

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Thoracotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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"surgical" method

Group Type EXPERIMENTAL

Thoracic paravertebral block

Intervention Type PROCEDURE

Intrathoracic method undergone through video assisted surgery (VATS

"anesthetic" method

Group Type ACTIVE_COMPARATOR

thoracic epidural analgesia

Intervention Type PROCEDURE

locoregional analgesia under ultrasound control

Interventions

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Thoracic paravertebral block

Intrathoracic method undergone through video assisted surgery (VATS

Intervention Type PROCEDURE

thoracic epidural analgesia

locoregional analgesia under ultrasound control

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No