Erector Spinae Plane Block Versus Serratus Plane Block in Breast Conserving Surgery: Α Randomized Controlled Trial.
Gianluca Vanni, Giordana Caiazza, Marco Materazzo...
https://pubmed.ncbi.nlm.nih.gov/34732440Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
FEMALE
ID06624917
Assessment of Oncological Safety, Quality of Life, and Environmental Impact of the Green Breast Surgery Protocol
Led by University of Rome Tor Vergata · Updated on 2024-10-03
110
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Breast cancer is the most common cancer diagnosis in women, with cases expected to rise due to population growth and aging. This research evaluates a new Green Breast Surgery protocol designed to reduce the environmental impact of breast cancer surgery while maintaining safety and quality of life. The study investigates how combining innovative surgical and telehealth methods affects clinical outcomes, patient-reported experiences, and environmental measures. The study compares the Green Breast Surgery protocol, which includes awake surgery with peripheral nerve blocks and reduced use of volatile anesthetics, to conventional surgery. Patients receive preoperative counseling, including lifestyle recommendations, and undergo surgery with specific environmental and recovery-focused practices. Postoperative care involves personalized thrombosis prevention, early mobilization, and telemedicine follow-ups. The study also applies a checklist to minimize operating room waste and emissions. Participants will have scheduled assessments of pain at rest and during movement at 24 and 48 hours, and 30 days after surgery, along with quality of life and patient-reported outcomes. Researchers will monitor hospital admissions, telehealth use, surgical complications, and the carbon footprint of surgeries. Follow-ups are conducted mainly through telemedicine, with complication checks at 30 days post-surgery. The study duration includes preoperative assessments through one month after surgery.
CONDITIONS
Brief Title
Assessment of Oncological Safety, Quality of Life, and Environmental Impact of the Green Breast Surgery Protocol
Who Can Participate
Age: 18Years - 75Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Patients candidates for Breast Conserving Treatment
- ASA score I-II
- Availability to Telehealth assessment in the postoperative period
- Female
- Aged between 18 and 75 years
You will not qualify if you...
- Drug addiction
- Contraindication for locoregional ultrasound-guided procedure (e.g., local infection, allergy to local anesthetics)
- Chronic pain under treatment
- Pregnancy
- No follow-up planned in the study facility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Treatment
Duration - Day of surgery and immediate post-operative period
Participants undergo breast conserving surgery using either the Green Breast Surgery Protocol with awake surgery and environmental impact reduction measures or conventional surgery, followed by a fast recovery approach.
1 day surgery visit plus immediate post-operative care
Post-operative Follow-up
Duration - 30 days after surgery
Participants are followed post-operatively with telemedicine visits, pain and quality of life assessments, and evaluation of complications up to 30 days after surgery.
Telemedicine follow-ups and assessments during 30 days post-surgery
Trial Site Locations
Total: 1 location
1
Università degli Studi di Roma Tor Vergata
Roma, Italy, 00133
Actively Recruiting
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Research Team
O
Oreste Claudio Buonomo, Full Prof
M
Marco Materazzo, PhD Fellow
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
From Patient Reported Outcome Measure (PROM) to Environment Related Outcome Measure (EROM): Towards "Green Breast Surgery".
Gianluca Vanni, Marco Materazzo, Marco Pellicciaro...
https://pubmed.ncbi.nlm.nih.gov/37369495