Erector Spinae Block in First Rib Resection: a Monocentric Before-after Study (MERCOTE)

November 14, 2019 updated by: University Hospital, Angers

Bloc Des Muscles Erecteurs du Rachis Pour Chirurgie d'exérèse de première côte Dans le Cadre du Syndrome du défilé Cervico-thoracique: évaluation Avant-après au CHU d'Angers.

First rib resection surgery for thoracic outlet syndrome is associated with an intense postoperative pain. It leads to significant consumption of nonsteroidal anti-inflammatory drugs and opioids, and hospitalization for several days.

In our center, first rib resection surgery was usually performed under general anesthesia combined with diffuse local infiltration of the axillary fossa. Erector spinae block is an interfascial block where a local anesthetic is injected between the erector spinae muscle and the transverse process, in order to obtain a multimetameric analgesia. It has now shown its efficacy and its safety in thoracic and abdominal surgeries by decreasing the morphine consumption and pain scores. Since November 2018, this erector spinae block is systematically performed preoperatively for first rib resection in our center, in association with a general anesthesia. Patient satisfaction seems important but remains to be assessed objectively.

In a before-after study, our goal is to assess the impact of the use of erector spinae block on postoperative pain in the first rib resection surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

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
      • Angers, France, 49100
        • Département d'Anesthésie-Réanimation du CHU d'Angers

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing first rib resection for thoracic outlet syndrome

Description

Inclusion Criteria:

  • First rib resection for thoracic outlet syndrome

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
Control
Patients in this group did not receive an erector spinae block. Data are obtained retrospectively (years 2017 and 2018).
Erector spinae block
Patients in this group receive an erector spinae block. Data will be obtained prospectively.
Procedure: Erector spinae block
Preoperative erector spinae block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment at H+48
Time Frame: Day 2 after surgery
Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain)
Day 2 after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Postoperative pain assessment at other times
Time Frame: Hour 2, Day 1, and Day 3 after surgery
Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain)
Hour 2, Day 1, and Day 3 after surgery
Total consumption of morphine (per and postoperative)
Time Frame: Hour 2, Day 1, Day 2 and Day 3 after surgery
Hour 2, Day 1, Day 2 and Day 3 after surgery
Frequency of adverse effects related to morphine Frequency of morphine side effects
Time Frame: Hour 2, Day 1, Day 2 and Day 3 after surgery
Hour 2, Day 1, Day 2 and Day 3 after surgery

Collaborators and Investigators

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

Sponsor

University Hospital, Angers

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 (ANTICIPATED)

November 1, 2019

Primary Completion (ANTICIPATED)

March 1, 2021

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (ACTUAL)

November 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2019/98

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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