Comparison of the Clinical Efficacy of 2 Paravertebral Block Strategies in Thoracic Surgery by Thoracotomy: by the Anesthetist (Paravertebral Block Guided by Ultrasound) and by the Thoracic Surgeon (Paravertebral Block Visual) (PVBS-USguided)

February 17, 2025 updated by: CHU de Reims

Comparison of the Clinical Efficacy of 2 Paravertebral Block Strategies in Thoracic Surgery by Thoracotomy: : by the Anesthetist (Paravertebral Block Guided by Ultrasound) and by the Thoracic Surgeon (Paravertebral Block Visual)

Post-thoracotomy pain is one of the most severe. The local analgesia allows its effective control and a reduction of postoperative morbidity and mortality.

The gold standard for local analgesia is the thoracic epidural. However, this technique can be dangerous with severe complications.

The paravertebral block showed comparable efficacy to the thoracic epidural for local analgesia . In addition, it has a better safety profile. There are several installation techniques. The difference in efficiency of these laying techniques is unknown.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Compare the clinical effectiveness of two strategies of realization of paravertebral block: by the anesthetist before incision (paravertebral block guided by ultrasound) and by the thoracic surgeon at chest closure (paravertebral block visual).

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • CHU de Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patient with thoracotomy indication for segmentectomy (s), lobectomy (s) lung or pulmonary wedge resection
  • patient consenting to participate to the study
  • patient enrolled in the national healthcare insurance program
  • patient older than 18 years

Exclusion Criteria:

  • patient with neuropathy
  • patient with body mass index superior to 35 kg/m2
  • patient with contraindication for paravertebral block or local analgesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound)
Other: paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound)
Active Comparator: control group
paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual)
Other: paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain
Time Frame: 24 hours
Pain evaluated using a visual analog pain scale
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2016

Primary Completion (Actual)

October 10, 2020

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimated)

August 12, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PA15082

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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