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)

NCT ID: NCT02865226

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-16

Study Completion Date

2021-09-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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experimental group

paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound)

Group Type EXPERIMENTAL

paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound)

Intervention Type OTHER

control group

paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual)

Group Type ACTIVE_COMPARATOR

paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual).

Intervention Type OTHER

Interventions

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paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound)

Intervention Type OTHER

paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu de Reims

Reims, , France

Site Status

Countries

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France

Other Identifiers

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PA15082

Identifier Type: -

Identifier Source: org_study_id

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