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NCT Number: NCT07737132

Comparison of Postoperative Analgesic Efficacy of Two Different Blocks in Modified Radical Mastectomy Surgery

Postoperative pain following modified radical mastectomy remains a significant clinical challenge and may delay recovery, impair patient comfort, and increase opioid consumption. Ultrasound-guided fascial plane blocks have become an important component of multimodal analgesia for breast surgery. The serratus anterior plane block (SAPB) is an established regional anesthesia technique that provides effective postoperative analgesia. The serratus posterior superior intercostal plane block (SPSIPB) is a recently described interfascial block with promising analgesic effects, but evidence comparing its efficacy with SAPB in breast surgery remains limited.

This prospective, randomized, double-blind, single-center clinical trial aims to compare the postoperative analgesic efficacy of ultrasound-guided SPSIPB and SAPB in patients undergoing modified radical mastectomy under general anesthesia. Seventy female patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be randomly assigned to receive either SPSIPB or SAPB before surgery. The primary outcome is postoperative pain intensity assessed using the Visual Analog Scale (VAS). Secondary outcomes include intraoperative remifentanil consumption, cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting (PONV), quality of recovery assessed with the QoR-40 questionnaire, rescue analgesic requirements, and block-related complications. The findings of this study are expected to provide evidence regarding the comparative effectiveness and safety of these two interfascial plane blocks for postoperative analgesia in breast cancer surgery.

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Key information

About this study

Breast cancer surgery, particularly modified radical mastectomy, is frequently associated with moderate to severe postoperative pain. Inadequate pain control may impair respiratory function, delay mobilization, prolong hospital stay, increase opioid consumption, and contribute to the development of persistent postsurgical pain. Therefore, effective multimodal analgesia incorporating regional anesthesia techniques has become an important component of perioperative care in breast surgery.

Among ultrasound-guided fascial plane blocks, the serratus anterior plane block (SAPB) has been widely adopted because of its ability to block the lateral cutaneous branches of the intercostal nerves, resulting in reduced postoperative pain scores and opioid requirements. More recently, the serratus posterior superior intercostal plane block (SPSIPB) has been introduced as a novel interfascial block that may provide broader thoracic dermatomal spread through injection between the serratus posterior superior and intercostal muscles. Although early clinical reports have demonstrated promising analgesic efficacy, comparative evidence between SPSIPB and SAPB in breast surgery remains limited.

This study is designed as a prospective, randomized, double-blind, single-center clinical trial to compare the analgesic efficacy of ultrasound-guided SPSIPB and SAPB in patients undergoing modified radical mastectomy under general anesthesia. Seventy female patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I-III who meet the eligibility criteria will be enrolled after providing written informed consent. Participants will be randomized in a 1:1 ratio using sealed-envelope allocation to receive either ultrasound-guided SPSIPB or SAPB before induction of general anesthesia. Both blocks will be performed using 30 mL of 0.25% bupivacaine under standardized ultrasound guidance by experienced anesthesiologists.

General anesthesia and postoperative analgesic management will be standardized for all participants. Intraoperative anesthetic management will include propofol, fentanyl, rocuronium, sevoflurane, and remifentanil according to institutional practice. Following surgery, all patients will receive standardized multimodal analgesia consisting of intravenous paracetamol, tramadol patient-controlled analgesia (PCA), and rescue analgesics when clinically indicated.

The primary outcome is postoperative pain intensity assessed using the Visual Analog Scale (VAS) at predefined postoperative time points. Secondary outcomes include intraoperative remifentanil consumption, cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting (PONV) scores, rescue analgesic requirements, quality of recovery measured using the QoR-40 questionnaire at 24 hours, block-related complications, and other postoperative adverse events.

The findings of this study are expected to clarify whether SPSIPB provides analgesia comparable or superior to SAPB for patients undergoing breast cancer surgery. The results may contribute to optimizing regional anesthesia strategies and improving postoperative recovery while reducing perioperative opioid consumption.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients aged 18 to 65 years.
  • Scheduled for elective modified radical mastectomy under general anesthesia.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Body mass index (BMI) <35 kg/m².
  • Normal coagulation profile (including INR and platelet count).
  • Normal liver and renal function tests.
  • Able to understand the study procedures and provide written informed consent.

Exclusion criteria

  • Known allergy or hypersensitivity to local anesthetics.
  • Coagulation disorders or bleeding diathesis.
  • Infection or inflammation at the planned block site.
  • ASA physical status IV or higher.
  • Chronic opioid use or chronic pain requiring long-term analgesic therapy.
  • Advanced hepatic or renal insufficiency.
  • Severe pulmonary disease.
  • Opioid use within 24 hours before surgery.
  • Cognitive impairment or inability to complete postoperative assessments.
  • Revision breast surgery.
  • Refusal to participate in the study.

Treatment and study plan

Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB)

Procedure

An ultrasound-guided serratus posterior superior intercostal plane block will be performed before induction of general anesthesia using 30 mL of 0.25% bupivacaine injected into the fascial plane between the serratus posterior superior muscle and the intercostal muscles.

Ultrasound-Guided Serratus Anterior Plane Block (SAPB)

Procedure

Ultrasound-guided injection of 30 mL of 0.25% bupivacaine into the serratus anterior plane before induction of general anesthesia.

Primary outcomes

  1. Postoperative pain intensity

    Time frame: 24 hours after surgery (assessed at PACU arrival, 30 minutes, 2, 4, and 24 hours postoperatively)

    Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded at predefined postoperative time points.

Secondary outcomes

  1. Intraoperative remifentanil consumption

    Time frame: During surgery

    Total intraoperative remifentanil consumption will be recorded in micrograms.

  2. Postoperative tramadol consumption

    Time frame: 24 hours after surgery

    Total tramadol consumption delivered by patient-controlled analgesia (PCA) during the first 24 postoperative hours.

  3. Postoperative nausea and vomiting

    Time frame: 24 hours after surgery

    Postoperative nausea and vomiting will be evaluated using a 5-point PONV score.

  4. Quality of recovery

    Time frame: 24 hours after surgery

    Quality of recovery will be evaluated using the Quality of Recovery-40 (QoR-40) questionnaire.

  5. Rescue analgesic requirement

    Time frame: 24 hours after surgery

    The number of patients requiring rescue analgesia and the total rescue analgesic dose administered will be recorded.

  6. Block-related complications

    Time frame: From block performance until 24 hours after surgery

    Complications associated with the regional block, including local anesthetic systemic toxicity, vascular puncture, pneumothorax, hematoma, infection, or block failure, will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Dilek M Yamac

CONTACT

[email protected]

05054959792

Dilek M Yamac, MD

CONTACT

[email protected]

+905054959792

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

Comparison of Postoperative Analgesic Efficacy of Superior Posterior Serratus Intercostal Plane Block (SPSIP) and Anterior Serratus Plane Block in Modified Radical Mastectomy Surgery

Acronym: mastectomy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 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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