NCT04579276

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

September 8, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2021

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

September 4, 2020

Last Update Submit

August 12, 2022

Conditions

Thoracotomy

Outcome Measures

Primary Outcomes (1)

  • total morphine consumption

    48 HOURS

Secondary Outcomes (4)

  • Time occupancy of the operating room

    1 MONTH

  • visual analog scale of pain (VAS)

    12 HOURS

  • visual analog scale of pain (VAS)

    48HOURS

  • visual analog scale of pain (VAS)

    30 DAYS

Study Arms (2)

"surgical" method

EXPERIMENTAL
Procedure: Thoracic paravertebral block

"anesthetic" method

ACTIVE COMPARATOR
Procedure: thoracic epidural analgesia

Interventions

Thoracic paravertebral blockPROCEDURE

Intrathoracic method undergone through video assisted surgery (VATS

"surgical" method
thoracic epidural analgesiaPROCEDURE

locoregional analgesia under ultrasound control

"anesthetic" method

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female ≥ 18 years of age.
  • VATS or RATS with lung resection including wedges, segmentectomies or lobectomies.
  • Signed consent.
  • Scheduled surgeries.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

assistance publique hôpitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

  • Chenesseau J, Fourdrain A, Pastene B, Charvet A, Rivory A, Baumstarck K, Bouabdallah I, Trousse D, Boulate D, Brioude G, Gust L, Vasse M, Braggio C, Mora P, Labarriere A, Zieleskiewicz L, Leone M, Thomas PA, D'Journo XB. Effectiveness of Surgeon-Performed Paravertebral Block Analgesia for Minimally Invasive Thoracic Surgery: A Randomized Clinical Trial. JAMA Surg. 2023 Dec 1;158(12):1255-1263. doi: 10.1001/jamasurg.2023.5228.

    PMID: 37878299DERIVED

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Emilie GARRIDO- PRADALIE

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

  • JOSEPHINE CHENESSEAU

    Assistance Publique Hopitaux De Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

October 8, 2020

Study Start

September 8, 2020

Primary Completion

December 8, 2021

Study Completion

December 8, 2021

Last Updated

August 15, 2022

Record last verified: 2022-08

Locations

FR(1)