PECS-II vs ESP in Nociception Level Index Guided Breast Surgery
Launched by KOÇ UNIVERSITY · May 24, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two methods of regional anesthesia, called PECS-II and Erector Spinae Plane (ESP) blocks, to see which one is more effective in reducing the need for opioids during breast surgery. The goal is to provide better pain management while minimizing the side effects associated with opioid medications, such as nausea and delayed recovery. The trial will include 90 women aged 18 to 80 who are scheduled for elective breast surgeries like mastectomy or breast reconstruction. Participants will be randomly assigned to one of three groups: one receiving the PECS-II block, another receiving the ESP block, and a control group that will not receive a block.
If you or someone you know is considering participation, eligible candidates should be in good health (ASA physical status I-III) and not have certain conditions, such as a high body mass index or chronic opioid use. Throughout the surgery, participants can expect to have their pain levels monitored closely, allowing for more precise adjustments to pain medication as needed. The study aims to provide valuable information on how these blocks can improve pain management and reduce reliance on opioids in breast surgery, contributing to safer and more effective care.
Gender
FEMALE
Eligibility criteria
- • Eligibility Criteria This study involves adult female patients undergoing elective breast surgery for benign or malignant conditions. The goal is to evaluate the effectiveness of regional anesthesia techniques (PECS-II and ESP blocks) in reducing intraoperative opioid consumption, guided by Nociception Level Index (NOL) monitoring.
- Inclusion Criteria:
- • Female patients aged 18 to 80 years ASA Physical Status Classification I-III
- Scheduled for elective unilateral or bilateral breast surgery, including one or more of the following:
- • Lumpectomy with axillary lymph node biopsy or dissection Breast reconstruction Breast reduction Mastopexy Implant expander removal or placement
- Exclusion Criteria:
- • Morbid obesity (BMI \> 40 kg/m²) Presence of non-sinus cardiac rhythm Chronic opioid use (defined as daily use for \>2 weeks in the last month or total use \>4 weeks) History of opioid abuse or dependence Comorbidities causing moderate to severe functional limitation Inability to communicate with study personnel or follow instructions Pregnancy or breastfeeding Known allergy or hypersensitivity to bupivacaine or any study-related medication
- • -
About Koç University
Koç University, a leading multidisciplinary research institution located in Istanbul, Turkey, is dedicated to advancing healthcare through innovative clinical research. With a commitment to excellence in education and research, the university fosters collaboration among experts in various fields, aiming to translate scientific discoveries into practical applications that improve patient outcomes. Koç University’s clinical trial initiatives are characterized by rigorous methodologies, ethical standards, and a focus on addressing pressing health challenges, positioning it as a pivotal player in the global research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Istanbul, , Turkey
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported