PECS-II versus ESP nerve blocks for pain control during breast surgery
NOL-Guided Intraoperative Remifentanil Consumption With PECS-II and Erector Spinae Plane Blocks in Breast Surgery: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Koç University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07002541 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Istanbul
- Koc University — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Ilayda Kalyoncu Karahan, MD
- Email: ilaydaakalyoncu@gmail.com
- Phone: +905325105014
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.