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.
UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2020-12-07
2021-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prospective Cases
These cases will be recruited prospectively, and receive the intercostal nerve block(s) on operated site(s). Peri-operative injections of 30 ml of 0.25% Bupivacaine each, injected over the 4th, 5th, and 6th ribs on the operated site(s).
Bupivacaine Hydrochloride
See group descriptions
Retrospective Controls
Controls will be gathered retrospectively from chart reviews where patient did not receive a intercostal nerve blocker bilaterally.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bupivacaine Hydrochloride
See group descriptions
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Bilateral or unilateral breast surgery including cancer extirpation, reconstruction (implant and expander), oncoplastic surgery (\<200 gm), breast augmentation and breast reduction, etc.
Exclusion Criteria
* Patients who cannot receive local anesthesia.
* Below the age of 20 and above the age of 70.
* Patients requiring reoperation due to complications of mammoplasty or another breast surgery.
* Poorly controlled diabetics, uncontrolled hypertension, heart disease, arrhythmias, diagnosed with bipolar and generalized anxiety disorders.
20 Years
70 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jewish Hospital and St. Mary's Healthcare
OTHER
Baptist Health
UNKNOWN
Kleinert, Kutz and Associates
OTHER
Christine M. Kleinert Institute for Hand and Microsurgery
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michelle Palazzo, MD
Role: PRINCIPAL_INVESTIGATOR
Christine M. Kleinert Institute for Hand and Microsurgery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ambulatory Surgery Center, Kleinert Kutz Hand Care Center
New Albany, Indiana, United States
Baptist Health Floyd
New Albany, Indiana, United States
Christine M Kleinert Institute for Hand and Microsurgery
Louisville, Kentucky, United States
HCCOC, Jewish Hospital
Louisville, Kentucky, United States
Baptist Health Louisville
Louisville, Kentucky, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Michelle Palazzo, MD
Role: primary
Michelle Palazzo, MD
Role: primary
Michelle Palazzo, MD
Role: primary
Julianne Sutton, MPH
Role: backup
Michelle Palazzo, MD
Role: primary
Michelle Palazzo, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Park JW, Kim JH, Woo KJ. Intraoperative Intercostal Nerve Block for Postoperative Pain Control in Pre-Pectoral versus Subpectoral Direct-to-Implant Breast Reconstruction: A Retrospective Study. Medicina (Kaunas). 2020 Jun 30;56(7):325. doi: 10.3390/medicina56070325.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20.0781
Identifier Type: -
Identifier Source: org_study_id