PECS-II versus ESP nerve blocks for pain control during breast surgery
Official title: NOL-Guided Intraoperative Remifentanil Consumption With PECS-II and Erector Spinae Plane Blocks in Breast Surgery: A Randomized Controlled Trial
Run by Koç University · NCT07002541 · Data updated 2026-11-12
This tests whether PECS-II or ESP nerve blocks better reduce intraoperative opioid use in adult women having elective breast surgery when anesthesia is guided by a Nociception Level Index monitor.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | Women only |
| Enrollment | 90 (estimated) |
| Sponsor | Koç University Academic / other |
| Locations | 1 site (Istanbul) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | June 1, 2025 |
| Study ends | June 30, 2025 |
| Registry record updated | June 3, 2025 |
| Trial ID | NCT07002541 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women aged 18–80 years with ASA physical status I–III scheduled for elective unilateral or bilateral breast surgery (for benign or malignant conditions) are the intended participants.
✕Probably not a fit
Patients with morbid obesity (BMI >40), non-sinus cardiac rhythms, chronic opioid use or opioid dependence, significant functional-limiting comorbidities, or inability to communicate are excluded and unlikely to benefit from the study interventions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adult female patients scheduled for elective unilateral or bilateral breast surgery receive either a PECS-II block or an erector spinae plane (ESP) block before anesthesia. Intraoperative opioid dosing is guided in real time by the Nociception Level Index (NOL) monitor to tailor analgesia. The primary focus is intraoperative opioid consumption, with attention to downstream outcomes such as postoperative pain and opioid-related side effects. The trial directly compares the two regional techniques to see which provides greater opioid-sparing when combined with NOL-guided anesthesia.
Why it matters
Potential benefit: If successful, one block approach could meaningfully reduce intraoperative opioid requirements and related side effects, improving recovery after breast surgery.
How similar studies have gone: Prior studies have shown both PECS-II and ESP blocks can reduce opioid needs after breast surgery, but direct comparisons under NOL-guided intraoperative anesthesia are limited.
Who can join: the full rules
Show full inclusion / exclusion 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 \-
Where it's running
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Koc University
Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Ilayda Kalyoncu Karahan, MD
- Email: ilaydaakalyoncu@gmail.com
- Phone: +905325105014
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.