- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04024683
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
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Dijon, France, 21000
- CHU Dijon Bourgogne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bouhemad - BEAL 2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Thoracic Surgery
-
Maquet Cardiopulmonary GmbHNAMSARecruitingCardiac Surgery | Cardiopulmonary Bypass | Thoracic Surgery | Vascular SurgerySpain
-
Vanderbilt UniversityEdwards LifesciencesCompletedCardiac Surgery | Thoracic Surgery | Heart Surgery | Heart Transplant
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedCardiac Surgery | Cardiopulmonary Bypass | Thoracic SurgeryNetherlands
-
Örebro University, SwedenRecruiting
-
Hospices Civils de LyonCompletedSurgery | ThoracicFrance
-
Hospital de Clinicas de Porto AlegreUNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)Completed
-
Universidade Federal de PernambucoReal Hospital Português de Beneficência em PernambucoCompleted
-
Universidade Federal de PernambucoUnknown
-
Hopital FochCompleted
-
Assaf-Harofeh Medical CenterUnknownThoracic Surgery
Clinical Trials on Serratus block with ropivacaine 2mg/ml
-
Erasme University HospitalUnknownChronic Pain | Postoperative Complication | Breast/Surgery
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPain, Postoperative | Serratus Anterior Plane Block | Thoracic Surgery, Video-Assisted | Local AnestheticTurkey
-
Lawson Health Research InstituteRecruitingPain Management | Video Assisted Thoracic Surgery (VATS)Canada
-
Centre Hospitalier Universitaire, AmiensCompletedPain, Postoperative | Anesthesia, LocalFrance
-
Centre Hospitalier Universitaire VaudoisCompletedPostoperative PainSwitzerland
-
Bispebjerg HospitalCompleted
-
Bezmialem Vakif UniversityRecruiting
-
Maisonneuve-Rosemont HospitalWithdrawnComplex Regional Pain Syndromes
-
Cairo UniversitySamuel Bekhet Moawad; Ahmed Shaker Ragab; Michael Wahib WadidCompletedU/S Guided SAB VS U/S Guided SAB Combined With Modified Pectoral Nerve BlockEgypt
-
Institut Mutualiste MontsourisFondation Ophtalmologique Adolphe de RothschildRecruitingAnalgesia | Anesthesia, Local | Pain SyndromeFrance