The Effect of the Ultrasound-guided Serratus Anterior Plane Block in Combinaison With Thoracic Paravertebral cathéter Versus Thoracic Paravertebral Cather for Perioperative Analgesia in Thoracic Surgery

July 16, 2019 updated by: Centre Hospitalier Universitaire Dijon

Introduction

The paravertebral catheter has been shown to be effective in controlling postoperative pain, but has never been associated with the deep dentate block in thoracic surgery. The objective of this study was to compare the efficacy of single-dose deep dentate block-level postoperative pain control in combination with a continuous perfusion paravertebral catheter versus continuous perfusion paravertebral catheter alone in controlled thoracic surgery.

Materials and methods

We retrospectively included 159 ASA I-III major patients who underwent scheduled thoracic surgery in the operating theater of Dijon University Hospital, between March and November 2018. All patients benefited from the same anesthetic protocol routinely used in controlled thoracic surgery. They were included in two groups: deep serrate deep group (GS) with a deep serrated deep serrate block immediately after orotracheal intubation with 0.2% Ropivacaine at 0.75 mg / kg and paravertebral catheter placed by the surgeon and put in charge at the fall of the surgical drapes versus control group (GC) benefiting from a paravertebral catheter alone. The primary endpoint was 24-hour morphine equivalent consumption. The criteria for secondary judgments were intraoperative remifentanil consumption, VAS at 0h, 24h and 48h, morphine consumption at 0h, 48h and the profile of the various complications. The morphine equivalent was calculated according to an equivalence table with reference to Oxycodone per os. Quantitative data are presented in median and standard deviation and were compared by Student's t-test or Wilcoxon test.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

159

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

      • Dijon, France, 21000
        • CHU Dijon Bourgogne

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with thoracic surgery in the operating theater of Dijon University Hospital

Description

Inclusion Criteria:

  • We included all patients over the age of 18 who met the classification criteria of the American Society of Anesthesiology (ASA) and had thoracic surgery in the operating theater of Dijon University Hospital

Exclusion Criteria:

  • Exclusion criteria were ASA 4 or higher, pregnant or breastfeeding women, minor patients, patients not able to use morphine PCA, and patients with chronic algia.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Serratus block group
Realization of a serratus block and para-vertebral catheter
The serratus block was made using a 50 mm needle with ultrasound guidance. It was performed supine, the ultrasound probe identifying the 3, 4 or 5th intercostal space and then the needle was introduced under ultrasound control
Control group
Realization of a para-vertebral catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
consumption of morphine equivalence
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
morphine consumption
Time Frame: 48 hours
48 hours
intraoperative remifentanil consumption,
Time Frame: 48 hours
48 hours
visual analogue scale
Time Frame: 48 hours
48 hours
intraoperative complications
Time Frame: Day 5
Day 5

Collaborators and Investigators

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

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)

March 1, 2018

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

July 15, 2019

First Submitted That Met QC Criteria

July 16, 2019

First Posted (Actual)

July 18, 2019

Study Record Updates

Last Update Posted (Actual)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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