Different Approaches to Thoracic Paravertebral Block (VAP BLOCK)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Thoracotomy

Treatments: Procedure: Thoracic paravertebral block; Procedure: thoracic epidural analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04579276

2020-11

2020-A00483-36 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

"surgical" method

Experimental group

Treatment:

Procedure: Thoracic paravertebral block

"anesthetic" method

Active Comparator group

Treatment:

Procedure: thoracic epidural analgesia