Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Patient Analgesia After Bloc Serratus (TraumaThorax)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04123977
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date October 3, 2019
First Posted Date October 11, 2019
Last Update Posted Date October 21, 2019
Actual Study Start Date October 1, 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 18, 2019)
Retrospective analysis of analgesia after Bloc serratus [ Time Frame: Files analysed retrospectily from January 1st, 2018 to February 28, 2019 will be examined ]
Original Primary Outcome Measures
 (submitted: October 10, 2019)
Retrospective study of the use of analgesia after Bloc serratus for the management of thoracic trauma [ Time Frame: Files analysed retrospectily from January 1st, 2018 to February 28, 2019 will be examined ]
Change History Complete list of historical versions of study NCT04123977 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Patient Analgesia After Bloc Serratus
Official Title Evaluation of Patient Analgesia After Bloc Serratus for the Management of Thoracic Trauma
Brief Summary

Thorax traumas are very common in severe traumatology, including road accidents, representing the second most frequent site (after head injury, according to the FIRST study). These thoracic lesions are the cause of many complications (pneumothorax, hemothorax, lung infections, atelectasis).

The national recommendations recommend the use of multi-modal analgesia with the use of regional loco anaesthesia for pain management and prevention of respiratory complications, including infectious complications. The loco-regional anaesthesia of choice is thoracic epidural or paravertebral block, but these techniques are not without risks, and are contraindicated in many situations (severe head trauma, patient under curative anticoagulation, pelvic trauma...).

The anterior Serratus block appears to be a quality localoregional anaesthesia in thoracic surgery, and a few cases in the literature have shown an interest in severe traumatology.

The investigators perform this anterior Serratus block almost systematically in patients with thoracic trauma in the Hautepierre surgical intensive care unit.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient hospitalised in surgical intensive care or continuous trauma care with thorax trauma who received anterior Serratus block analgesia from January 1, 2018 to February 28, 2019
Condition Thorax Traumas
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 10, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

  • Adult patient (≥18 years old)
  • Gender (Male and Female)
  • Patient hospitalised in surgical intensive care or continuous trauma care with thorax trauma who received anterior Serratus block analgesia from January 1, 2018 to February 28, 2019
  • Patient who has given his consent to the reuse of his data for the purposes of this research

Criteria for non-inclusion:

  • Patient who has expressed opposition to participating in the study
  • Impossibility of giving the subject informed information (difficulties in understanding the subject,...)
  • Subject under the protection of justice
  • Subject under guardianship or curatorship
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Julien POTTECHER, MD, PhD 33 3 88 12 70 95 julien.pottecher@chru-strasbourg.fr
Contact: Kevin COGNE, MD 33 3.88 12 61 55 kevin.cogne@chru-strasbourg.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04123977
Other Study ID Numbers 7406
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Strasbourg, France
Study Sponsor University Hospital, Strasbourg, France
Collaborators Not Provided
Investigators
Study Director: Julien POTTECHER, MD, PhD University Hospital, Strasbourg, France
PRS Account University Hospital, Strasbourg, France
Verification Date October 2019