Different Approaches to Thoracic Paravertebral Block

Not Applicable

Completed

• Conditions: Thoracotomy
• Interventions: Procedure: Thoracic paravertebral block; Procedure: thoracic epidural analgesia

• Registration Number: NCT04579276
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Study Timeline

• Study First Submitted: 2020-09-04
• Study Start: 2020-09-08
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-08
• Primary Completion: 2021-12-08
• Study Completion: 2021-12-08
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-12
• Last Update Posted: 2022-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"surgical" method	Thoracic paravertebral block	-
"anesthetic" method	thoracic epidural analgesia	-

Primary Outcome Measures

Name	Time	Method
total morphine consumption	48 HOURS

Secondary Outcome Measures

Name	Time	Method
visual analog scale of pain (VAS)	30 DAYS
Time occupancy of the operating room	1 MONTH

Trial Locations

Locations (1)

assistance publique hôpitaux de Marseille; 🇫🇷 Marseille, France