Clinical trial NCT04579276: Different Approaches to Thoracic Paravertebral Block
Official title: Different Approaches to Thoracic Paravertebral Block: a Monocentric Randomized Study Comparing Ultrasounded-guided Method to Intrathoracic Visual Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracotomy
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: total morphine consumption
timeFrame: 48 HOURS
Secondary outcomes:
measure: Time occupancy of the operating room
timeFrame: 1 MONTH
measure: visual analog scale of pain (VAS)
timeFrame: 12 HOURS
measure: visual analog scale of pain (VAS)
timeFrame: 48HOURS
measure: visual analog scale of pain (VAS)
timeFrame: 30 DAYS
Other outcomes:
Locations:
city: Marseille
country: France
facility: assistance publique hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Emilie GARRIDO- PRADALIE
role: STUDY_DIRECTOR
affiliation: Assistance Publique Hopitaux De Marseille
name: JOSEPHINE CHENESSEAU
role: PRINCIPAL_INVESTIGATOR
References: