Different Approaches to Thoracic Paravertebral Block

Thoracotomy Clinical Trial

— VAP BLOCK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04579276
• Other study ID #: 2020-11
• Secondary ID: 2020-A00483-36
• Status: Completed
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: December 8, 2021

Study information

• Verified date: August 2022
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 8, 2021
• Est. primary completion date: December 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thoracotomy

Intervention

Procedure:
• Thoracic paravertebral block
Intrathoracic method undergone through video assisted surgery (VATS
• thoracic epidural analgesia
locoregional analgesia under ultrasound control

Locations

Country	Name	City	State
France	assistance publique hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total morphine consumption		48 HOURS
Secondary	Time occupancy of the operating room		1 MONTH
Secondary	visual analog scale of pain (VAS)		12 HOURS
Secondary	visual analog scale of pain (VAS)		48HOURS
Secondary	visual analog scale of pain (VAS)		30 DAYS