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Clinical Trials/NCT04579276
NCT04579276CompletedNot Applicable

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

Assistance Publique Hopitaux De Marseille1 site in 1 country180 target enrollmentStarted: September 8, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
180
Locations
1
Primary Endpoint
total morphine consumption

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.
  • •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.

Arms & Interventions

"surgical" method

Experimental

Intervention: Thoracic paravertebral block (Procedure)

"anesthetic" method

Active Comparator

Intervention: thoracic epidural analgesia (Procedure)

Outcomes

Primary Outcomes

total morphine consumption

Time Frame: 48 HOURS

Secondary Outcomes

  • visual analog scale of pain (VAS)(30 DAYS)
  • Time occupancy of the operating room(1 MONTH)
  • visual analog scale of pain (VAS)(48HOURS)
  • visual analog scale of pain (VAS)(12 HOURS)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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