Different Approaches to Thoracic Paravertebral Block

Study Overview
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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).

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.

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

Conditions
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Thoracotomy

Intervention / Treatment
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* Procedure: Thoracic paravertebral block
* Procedure: thoracic epidural analgesia


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total morphine consumption |  | 48 HOURS | 

Secondary Outcome Measures

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