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PECS-II vs ESP in Nociception Level Index Guided Breast Surgery

RecruitingNAAges 18 Years - 80 YearsFemaleKoç University
NCT07002541 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: Breast surgery is often associated with significant perioperative pain. While systemic opioids are commonly used, their side effects (nausea, vomiting, respiratory depression, delayed recovery) have encouraged the adoption of regional anesthesia techniques for better analgesia and reduced opioid requirements. PECS-II and Erector Spinae Plane (ESP) blocks are two effective regional techniques frequently utilized in breast surgery. However, comparative data on their impact on intraoperative opioid consumption under nociception-guided anesthesia remains limited. The Nociception Level Index (NOL) is an objective monitoring tool that integrates multiple physiological signals (e.g., heart rate variability, skin conductance, pulse amplitude) to assess nociceptive responses in real-time. When used intraoperatively, it enables more precise opioid titration, potentially optimizing an

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📋 Eligibility rules (as published)
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 \-
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What it tests

  • PECS II block
  • ESP block
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Where

1 site
Koc University
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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