Clinical trial Recruiting at 1 site Interventional Ages 18 to 80 Women only

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 typeInterventional
Ages18 Years to 80 Years
SexWomen only
Enrollment90 (estimated)
SponsorKoç University
Academic / other
Locations1 site (Istanbul)
StatusRecruiting
StartedDecember 1, 2024
Main results expectedJune 1, 2025
Study endsJune 30, 2025
Registry record updatedJune 3, 2025
Trial IDNCT07002541 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

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Where it's running

  • Koc University
    Istanbul, Turkey (Türkiye)
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.