Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
126 participants
INTERVENTIONAL
2020-03-06
2020-05-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Regional Anesthesia for Breast Surgery
NCT03941223
Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial
NCT06028126
Parasternal Subpectoral Plane Blocks for Cardiac Surgery Via a Midline Sternotomy
NCT04788056
The Use of Serratus Block for Cardiac Surgery
NCT03237546
Pectoral Nerve Block for Analgesia After Breast Augmentation
NCT02682186
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Interventional (parasternal group)
2. Case control group The "parasternal group" of patients will receive the pre-operative parasternal block (20 ml of 0.5% Ropivacaine per side) in association with infiltration with local anesthetic of access to thoracic drainage (drainage infiltration with 20 ml of 0.25% Ropivacaine) at the end of the intervention combined to General Anesthesia.
The "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Parasternal Group
The "parasternal group" of patients will receive the pre-operative parasternal block (20 ml of 0.5% Ropivacaine per side) in association with infiltration with local anesthetic of access to thoracic drainage (drainage infiltration with 20 ml of 0.25% Ropivacaine) at the end of the intervention combined to General Anesthesia.
Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage
After induction of general anesthesia we will perform an ultrasound-guided Parasternal Block in association with infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.
Case control group
The "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids.
Infiltration with local anesthetic of access to thoracic drainage
Infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage
After induction of general anesthesia we will perform an ultrasound-guided Parasternal Block in association with infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.
Infiltration with local anesthetic of access to thoracic drainage
Infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age over 18 years
* ASA I-IV
* Approval by the patient of informed consent
Exclusion Criteria
* Puncture site infection
* Lack of signing of informed consent
* Weight \<30 Kg
* Age \<18 years
* Emergency interventions
* ASA \> IV
* Sternal dehiscences
* Dementia (for difficulties in managing weaning from mechanical ventilation and pain)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Campus Bio-Medico University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Giulia Nonnis
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Campus Biomedico University
Rome, Roma, Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20/20 PAR ComEt CBM
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.