PECS-II vs ESP in Nociception Level Index Guided Breast Surgery
NCT07002541 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2025-06-03
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 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 analgesia while minimizing opioid exposure.
Objective:
To compare the efficacy of PECS-II and ESP blocks in reducing intraoperative remifentanil consumption during breast surgery under general anesthesia guided by NOL monitoring.
Methods:
This prospective, randomized controlled trial was conducted at Koç University Hospital following ethical approval. Ninety female patients aged 18-80 years, classified as ASA I-III and scheduled for elective mastectomy or other breast surgeries, were randomly assigned into three groups (n=30 each):
Group 1 (PECS-II Block) Group 2 (ESP Block) Group 3 (Control - no block) Regional blocks were performed before surgery with ultrasound guidance. PECS-II block was administered at the 3rd to 5th rib levels in the mid-axillary line using 30 mL of 0.3% bupivacaine. ESP block was applied at T2-T5 levels with a total of 20 mL 0.5% bupivacaine.
All patients received standardized general anesthesia, including propofol, fentanyl, rocuronium, and desflurane maintenance. Remifentanil infusion (0.05-0.1 μg/kg/min) was titrated based on NOL values every 5 minutes: increased by 0.03 μg/kg/min if NOL \>25, and decreased by 0.03 μg/kg/min if NOL \<10.
Data collected included:
Total intraoperative remifentanil consumption (primary outcome) NOL scores every 5 minutes Postoperative pain scores (NRS) at 1st, 6th, 12th, and 24th hours (at rest and with arm abduction) Total opioid consumption (morphine, tramadol) in the first 24 hours Opioid-related side effects (nausea, vomiting, pruritus) Length of hospital stay Blinding was applied to data collectors (pain nurses and anesthesia technicians), but due to the nature of the procedures, surgeons and anesthesiologists were not blinded.
Statistical Analysis:
Data were analyzed using SPSS v26. Continuous variables were tested for normality (Shapiro-Wilk), and analyzed with t-tests or Mann-Whitney U as appropriate. Categorical variables were compared using Chi-square tests. Significance was set at p\<0.05.
Expected Outcomes and Contribution:
It is hypothesized that both PECS-II and ESP blocks will significantly reduce intraoperative remifentanil consumption compared to the control group. Furthermore, these blocks may improve postoperative pain control, reduce opioid-related side effects, and shorten recovery time.
This study aims to clarify the relative efficacy of two widely used regional blocks in the context of objective, nociception-guided anesthesia. The findings are expected to support evidence-based use of regional techniques in breast surgery and contribute to the growing body of literature emphasizing opioid-sparing strategies in perioperative care.
Conditions
- Intraoperative Pain
- Postoperative Pain
Interventions
- PROCEDURE
-
PECS II block
The PECS-II block is an ultrasound-guided interfascial plane block designed to provide analgesia for surgeries involving the anterolateral chest wall, particularly breast surgery. It is an extension of the PECS-I block, which targets the medial and lateral pectoral nerves. In the PECS-II technique, a high-frequency linear ultrasound probe is used to identify the fascial planes. A 22G, 50 mm regional block needle is advanced in-plane under sterile conditions. A total of 30 mL of 0.25% bupivacaine is administered: 10 mL is injected between the pectoralis major and minor muscles (targeting the pectoral nerves), and 20 mL between the pectoralis minor and serratus anterior muscles (to block the lateral branches of intercostal nerves and intercostobrachial nerve).
- PROCEDURE
-
ESP block
The erector spinae plane (ESP) block is a fascial plane block performed under ultrasound guidance to provide multimodal analgesia for thoracic and abdominal surgeries, including breast procedures. In this technique, a high-frequency linear ultrasound probe is used to visualize the transverse process of the thoracic vertebra, typically at the T4-T5 level. With the patient in a seated position and under standard sterile conditions, a 22G, 50 mm regional block needle is inserted in-plane until the tip reaches the fascial plane between the erector spinae muscle and the transverse process. After negative aspiration, 1-2 mL of test dose is injected to confirm correct needle placement by observing separation of fascial layers. Then, 20 mL of 0.25% bupivacaine is injected incrementally.
Sponsors & Collaborators
-
Koç University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-01
- Primary Completion
- 2025-06-01
- Completion
- 2025-06-30
Countries
- Turkey (Türkiye)
Study Locations
More Related Trials
-
Pectoral Nerve Block and Serratus Posterior Superior Intercostal Plane Block in Breast Cancer Surgery
NCT07001657 ·Status: COMPLETED ·Phase: NA
-
Ultrasound Guided Erector Spinae Plane Block
NCT06657092 ·Status: COMPLETED ·Phase: NA
-
Chronic Pain in Post-Mastectomy Patients; The Difference Between Pectoral Nerve (PECS I-II) and Erector Spinal Plane (ESP) Blocks
NCT06900842 ·Status: COMPLETED
-
Comparing Post-operative Analgesia After (PECS II) Block and (ESPB) in Modified Radical Mastectomy
NCT06714682 ·Status: COMPLETED ·Phase: NA
-
ESP vs Retrolaminar Block: A Randomized Trial
NCT07200960 ·Status: COMPLETED ·Phase: NA
-
PECS I Block vs. Local Infiltration in Breast Augmentation Pain Management
NCT06719726 ·Status: COMPLETED ·Phase: NA
-
A Comparative Study of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block on Postoperative Opioid Consumption Following Breast and Axillary Dissection Surgery
NCT06833697 ·Status: COMPLETED ·Phase: NA
-
Erector Spinae Block Versus PECS Block Type II for Breast Surgeries
NCT04284124 ·Status: COMPLETED ·Phase: NA
-
COMPARISON OF ERECTOR SPINA PLAN BLOCK AND THORACIC PARAVERTEBRAL BLOCK FOR PERIOPERATIVE ANALGESIA
NCT07021651 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Comparison of Erector Spina Plane Block and Thoracic Epidural Block
NCT04702061 ·Status: COMPLETED ·Phase: NA
-
The Effects of Erector Spinae Plane Block on Pain Scores in Unilateral Breast Cancer Surgery
NCT07134933 ·Status: COMPLETED ·Phase: NA
-
Paravertebral Block Versus Erector Spinae Plane Block for Analgesia in Modified Radical Mastectomy
NCT05080985 ·Status: COMPLETED ·Phase: NA
-
ESP in Breast Surgery Due to Cancer
NCT04726878 ·Status: COMPLETED ·Phase: PHASE4
-
Efect of Erector Spina Plane Block on Mastectomy
NCT04824300 ·Status: COMPLETED ·Phase: NA
-
Combined PECS II and Transversus Plane Blocks Versus Erector Spinae Block in Modified Radical Mastectomy
NCT03903224 ·Status: COMPLETED ·Phase: NA
-
Different Volumes of Erector Spinae Plane Block for Breast Surgery
NCT05232084 ·Status: COMPLETED ·Phase: NA
-
Comparison of the Effect of Preemptive and Post-operative Erector Spina Plane Block on Intraoperative Opioid Consumption and Postoperative Analgesia in Patients Who Will Undergo Elective Thoracotomy Surgery, Guided by the Nociception Level Index (NoL)
NCT05944523 ·Status: COMPLETED ·Phase: NA
-
Serratus Plane Block vs Erector Spinae Plane Block on Postoperative Analgesia in Patients Undergoing Unilateral Breast Surgery
NCT04218149 ·Status: COMPLETED ·Phase: PHASE4
-
IPP-PSP Block vs. SPSIPB in Breast Surgery
NCT07246720 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Comparison of ESP and SPSIP Blocks in Breast Surgery
NCT06611644 ·Status: COMPLETED ·Phase: NA
-
The Pectoralis (PECS2) Block Versus Intrathecal Morphine
NCT06016205 ·Status: UNKNOWN ·Phase: NA
-
Ultrasound Guided Modified Pectoral Plane Block Versus Erector Spinae Plane Block During GA in Gynecomastia Surgery
NCT04221074 ·Status: COMPLETED ·Phase: NA
-
Ultrasound Guided Rhomboid Intercostal and Subserratus Plane Block in Breast Cancer Surgeries
NCT04336917 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of PECS II Block and Combined Serratus Anterior Plane Block to Reduce Acute Pain After Mastectomy
NCT05961735 ·Status: COMPLETED
-
The Effect of Ultrasonography-guided Fascial Plane Blocks in Breast Cancer Surgery Patients
NCT06419504 ·Status: COMPLETED