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NCT Number: NCT07510269

Investigation of the Effects of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block on Perioperative Analgesia Management in Patients Scheduled for Mastectomy

This study aims to evaluate and compare the analgesic efficacy of two ultrasound-guided regional anesthesia techniques, the serratus anterior plane (SAP) block and the serratus posterior superior intercostal plane (SPSIP) block, in patients undergoing elective mastectomy surgery. Postoperative pain following mastectomy is a common and significant clinical problem that negatively affects patient comfort, delays mobilization, and may prolong hospital stay. Although systemic analgesics are commonly used, they are associated with adverse effects such as sedation, constipation, and potential dependency.

In this randomized clinical study, female patients aged 18-75 years with ASA physical status I-III scheduled for elective mastectomy will be included after obtaining informed consent. Patients will be allocated into two groups to receive either SAP block or SPSIP block under ultrasound guidance prior to surgery. Standardized general anesthesia and perioperative analgesia protocols will be applied to all patients.

The primary objective is to compare postoperative pain scores between the two groups using the Numeric Rating Scale (NRS). Secondary outcomes include time to first analgesic requirement, total analgesic consumption, intraoperative opioid use, and hemodynamic parameters. By comparing these two interfascial plane blocks, this study aims to identify a more effective analgesic technique that improves postoperative pain control, enhances patient comfort, and facilitates early mobilization following mastectomy.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Postoperative pain following mastectomy surgery remains a significant clinical concern, as it negatively impacts patient comfort, delays recovery, and may prolong hospital stay. Effective pain management is essential not only to improve patient satisfaction but also to reduce complications associated with delayed mobilization. Although systemic opioids and other analgesics are frequently used, they are associated with adverse effects such as sedation, nausea, constipation, and risk of dependency. Therefore, regional anesthesia techniques have gained increasing importance as part of multimodal analgesia strategies.

Ultrasound-guided interfascial plane blocks, such as the serratus anterior plane (SAP) block and the serratus posterior superior intercostal plane (SPSIP) block, have been shown to provide effective analgesia for thoracic and breast surgeries by targeting similar dermatomal distributions. However, comparative data regarding their relative efficacy in mastectomy patients are limited. This study aims to compare these two techniques in terms of postoperative analgesia and recovery outcomes.

Female patients aged between 18 and 75 years, classified as ASA physical status I, II, or III, and scheduled for elective mastectomy will be included in the study after obtaining written informed consent. Patients will be randomly assigned into two groups.

In Group 1, patients will receive an ultrasound-guided SAP block using a linear probe under aseptic conditions. The block will be performed in the lateral decubitus position by advancing the needle between the second and seventh ribs to the plane beneath the serratus anterior muscle, and 30 mL of 0.25% bupivacaine will be administered.

In Group 2, patients will receive an ultrasound-guided SPSIP block under aseptic conditions in the sitting position. The needle will be inserted medially to the scapula between the second and seventh ribs, targeting the plane between the serratus posterior superior muscle and intercostal muscles, and 30 mL of 0.25% bupivacaine (maximum dose 2 mg/kg/day) will be administered.

All patients will undergo standardized general anesthesia, including induction with midazolam, lidocaine, propofol, fentanyl, and rocuronium, followed by maintenance with desflurane at 1 MAC. Standard intraoperative monitoring (heart rate, blood pressure, oxygen saturation, end-tidal CO₂, and ECG) will be applied. Intraoperative administration of paracetamol, tenoxicam, and granisetron will be performed routinely.

Hemodynamic parameters will be recorded at 30-minute intervals during surgery. Total intraoperative opioid consumption, duration of surgery, and anesthesia time will also be documented. At the end of surgery, neuromuscular blockade will be reversed with sugammadex.

Postoperative pain will be assessed by a blinded investigator using the Numeric Rating Scale (NRS) at 0, 30 minutes, and at 1, 2, 4, 8, 12, 24, 36, and 48 hours. Time to first analgesic requirement, additional analgesic use, and total consumption will be recorded.

Patients with NRS ≥4 will receive intravenous paracetamol as first-line rescue analgesia. If pain persists, intravenous opioid (1 mg/kg) will be administered as second-line rescue analgesia.

Secondary outcomes include postoperative complications, pain during first mobilization, and patient and surgeon satisfaction assessed using a 5-point Likert scale.

Statistical analysis will be performed using SPSS version 25. Normality of data will be assessed using Kolmogorov-Smirnov and Shapiro-Wilk tests. Parametric or non-parametric tests will be used accordingly. Independent samples t-test or Mann-Whitney U test will be used for comparisons between groups, while paired t-test or Wilcoxon test will be used for within-group comparisons. ANOVA or Kruskal-Wallis tests will be used for comparisons involving more than two groups. A p-value <0.05 will be considered statistically significant.

This study is expected to determine the comparative effectiveness of SAP and SPSIP blocks in reducing postoperative pain, minimizing analgesic consumption, and improving recovery outcomes in patients undergoing mastectomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients aged between 18 and 75 years
  • Patients scheduled for elective mastectomy surgery
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Patients who provide written informed consent

Exclusion criteria

  • Patients who refuse to participate in the study
  • Patients with American Society of Anesthesiologists (ASA) physical status IV or V
  • Patients receiving anticoagulant therapy or with suspected coagulopathy
  • Patients with known allergy to local anesthetic agents
  • Infection at the site of block application
  • Pregnant patients or those with suspected pregnancy
  • Patients with severe neurological or psychiatric disorders
  • Patients with severe cardiovascular disease
  • Patients with chronic opioid use
  • Patients with hepatic failure or renal failure (glomerular filtration rate <15 mL/min/1.73 m²)

Treatment and study plan

SAP Block

Procedure

Under ultrasound guidance with a linear probe, the needle is inserted along the posterior axillary line between the second and seventh ribs and advanced into the plane between the serratus anterior muscle and the rib surface. A total of 30 mL of 0.25% bupivacaine (maximum dose 2 mg/kg/day) is injected.

SPSIP Block

Procedure

Under ultrasound guidance with a linear probe, the superomedial border of the scapula on the operative side is identified. The needle is inserted medial to the scapula between the second and seventh ribs and advanced into the interfascial plane between the serratus posterior superior muscle and the intercostal muscles. Subsequently, 30 mL of 0.25% bupivacaine (maximum dose 2 mg/kg/day) is administered.

Primary outcomes

  1. Postoperative Pain Intensity

    Time frame: Within 48 hours postoperatively

    Postoperative pain intensity and time to first analgesic requirement will be evaluated. Pain will be assessed using the Numeric Rating Scale (NRS, 0-10) at 0 and 30 minutes, and at 1, 2, 4, 8, 12, 24, 36, and 48 hours postoperatively, both at rest and during movement, by a blinded investigator

Secondary outcomes

  1. Total Analgesic Consumption

    Time frame: Within 48 hours postoperatively

    Total consumption of additional analgesics (paracetamol and opioid) will be recorded.

  2. Additional Analgesic Requirement

    Time frame: Within 48 hours postoperatively

    The number of patients requiring additional analgesia and the frequency of administration will be recorded.

  3. Intraoperative Opioid Consumption

    Time frame: During surgery

    The total amount of opioids administered intraoperatively will be recorded.

  4. Intraoperative mean arterial pressure (mmHg)

    Time frame: Every 30 minutes intraoperatively

    Mean arterial pressure (mmHg) will be recorded at 30 minute intervals during surgery and summarized as mean values.

  5. Postoperative Complications

    Time frame: Within 48 hours postoperatively

    Postoperative complications such as nausea, vomiting or other adverse events will be recorded.

  6. Pain During First Mobilization

    Time frame: Within 48 hours postoperatively

    Pain during first mobilization will be assessed using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.

  7. Patient satisfaction score

    Time frame: At the 24th hour post-operation

    evaluated using a 5-point Likert scale (1=very dissatisfied, 5=very satisfied)

  8. Surgeon satisfaction score

    Time frame: Within 24 hours postoperatively

    The primary surgeon's satisfaction will the analgesia quality and ease of the procedure, evaluated using a 5-point Likert scale (1= very dissatisfied , 5= very satisfied)

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

Mastektomi Planlanan Hastalarda Serratus Posterior Superior İnterkostal Plan Bloğu Ile Serratus Anterior Plan Bloğunun Peroperatif Analjezi Yönetimi Üzerine Etkilerinin Araştırılması

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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