Status:
RECRUITING
PECS-II vs ESP in Nociception Level Index Guided Breast Surgery
Lead Sponsor:
Koç University
Conditions:
Intraoperative Pain
Postoperative Pain
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
Background: Breast surgery is often associated with significant perioperative pain. While systemic opioids are commonly used, their side effects (nausea, vomiting, respiratory depression, delayed rec...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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
- \-
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07002541
Start Date
December 1 2024
End Date
June 30 2025
Last Update
June 3 2025
Active Locations (1)
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1
Koc University
Istanbul, Turkey (Türkiye)