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NCT Number: NCT07661212

Timing of Serratus Anterior Plane Block in Mastectomy Surgery

Postoperative pain following mastectomy may adversely affect early mobilization, patient comfort, and overall quality of recovery. Serratus anterior plane block is an ultrasound-guided regional anesthesia technique that provides analgesia to the anterolateral thoracic wall and is increasingly used as part of multimodal analgesia for breast surgery. Although the analgesic efficacy of serratus anterior plane block has been investigated in breast surgery, the clinical impact of the timing of block administration remains insufficiently defined.

This prospective, randomized, controlled, patient and assessor blinded clinical trial will compare two different timings of ultrasound-guided serratus anterior plane block in adult female patients undergoing elective unilateral mastectomy under general anesthesia. Participants will be randomized to receive serratus anterior plane block either after induction of general anesthesia and before surgical incision, or after completion of surgery and before extubation. In both groups, the block will be performed under ultrasound guidance using 25 mL of 0.25% bupivacaine.

The primary outcome is postoperative quality of recovery at 24 hours, assessed using the Quality of Recovery-15 questionnaire. Secondary outcomes include postoperative pain scores at predefined time points during the first 24 postoperative hours, intraoperative remifentanil consumption, postoperative opioid and non-opioid analgesic requirements, time to first analgesic requirement, postoperative nausea and vomiting, length of hospital stay, complications, inflammatory response markers including CRP and neutrophil-to-lymphocyte ratio, and intraoperative hemodynamic variables.

The study is planned to enroll 80 participants at a single tertiary training and research hospital. The findings are expected to clarify whether preincisional administration of serratus anterior plane block provides superior postoperative recovery, analgesic efficacy, and modulation of inflammatory response compared with administration at the end of surgery.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location contact

Fatma Çiğdem ÖZAKIN, MD

CONTACT

[email protected]

+905464168250

Fatma Çiğdem ÖZAKIN, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients aged 18 years or older
  • Scheduled for elective unilateral mastectomy surgery
  • Planned to undergo surgery under general anesthesia
  • American Society of Anesthesiologists physical status I-III
  • Willing and able to participate in the study
  • Provision of written informed consent

Exclusion criteria

  • Refusal to participate in the study
  • Known allergy to local anesthetics planned for use in the study
  • Chronic opioid use
  • Current steroid or immunosuppressive therapy
  • Presence of chronic inflammatory disease
  • Surgical duration shorter than 30 minutes
  • Active infection
  • Coagulopathy
  • Infection at the planned block site
  • Pregnancy or lactation
  • Advanced hepatic failure or advanced renal failure
  • Reoperation due to recurrent disease
  • Inability to communicate adequately or to provide reliable pain scores
  • Psychiatric or neurological condition limiting reliable completion of the QoR-15 questionnaire or Numeric Rating Scale assessments

Treatment and study plan

Ultrasound-Guided Serratus Anterior Plane Block

Procedure

Ultrasound-guided serratus anterior plane block will be performed under general anesthesia on the operative side. With the patient in the supine position and the ipsilateral arm abducted, a high-frequency linear ultrasound probe will be placed at the midaxillary line around the fourth to fifth intercostal level. After identification of the latissimus dorsi and serratus anterior muscles, the block needle will be advanced using an in-plane technique, and 25 mL of 0.25% bupivacaine will be injected into the fascial plane between these muscles after negative aspiration. In the preincisional arm, the block will be performed after induction of general anesthesia and before surgical incision. In the end-of-surgery arm, the same block will be performed after completion of surgery and before extubation.

Other names: SAP Block

Bupivacaine

Drug

Bupivacaine 0.25%, 25 mL (62.5 mg), will be administered as a single ultrasound-guided injection into the serratus anterior plane on the operative side. In the preincisional arm, administration will occur after induction of general anesthesia and before surgical incision. In the end-of-surgery arm, administration will occur after completion of surgery and before extubation.

Primary outcomes

  1. Postoperative Quality of Recovery at 24 Hours

    Time frame: 24 hours after surgery

    Postoperative quality of recovery will be assessed using the Quality of Recovery-15 questionnaire. The postoperative 24-hour QoR-15 score will be compared between the preincisional serratus anterior plane block group and the end-of-surgery serratus anterior plane block group. Higher scores indicate better quality of recovery.

Secondary outcomes

  1. Resting Postoperative Pain Scores

    Time frame: Postoperative 0 to 24 hours

    Resting pain intensity will be assessed using the Numeric Rating Scale at postoperative 0, 1, 4, 8, 12, 16, 20, and 24 hours.

  2. Intraoperative Remifentanil Consumption

    Time frame: During surgery

    Total intraoperative remifentanil consumption will be recorded and compared between groups.

  3. Postoperative Opioid Consumption

    Time frame: Postoperative 0 to 24 hours

    Total opioid consumption during the first 24 postoperative hours will be calculated based on tramadol use.

  4. Postoperative Non-Opioid Analgesic Consumption

    Time frame: Postoperative 0 to 24 hours

    Total non-opioid analgesic consumption during the first 24 postoperative hours will be recorded, including paracetamol use.

  5. Time to First Analgesic Requirement

    Time frame: Postoperative 0 to 24 hours

    The time from admission to the postoperative recovery unit to the first requirement for rescue analgesia will be recorded.

  6. Postoperative Nausea and Vomiting

    Time frame: Postoperative 0 to 24 hours

    The occurrence of postoperative nausea and vomiting will be assessed during the first 24 postoperative hours.

  7. Length of Hospital Stay

    Time frame: From surgery until hospital discharge, assessed up to 30 days.

    Length of hospital stay will be recorded as the number of days from surgery to discharge.

  8. C-Reactive Protein Level

    Time frame: Postoperative 6 hours

    Serum C-reactive protein concentration will be measured as a marker of postoperative inflammatory response and reported in mg/L.

  9. White Blood Cell Count

    Time frame: Postoperative 6 hours

    Absolute neutrophil count will be measured from the complete blood count and reported in ×10^9/L.

  10. Absolute Neutrophil Count

    Time frame: Postoperative 6 hours

    Absolute neutrophil count will be measured from the complete blood count and reported in ×10^9/L.

  11. Absolute Lymphocyte Count

    Time frame: Postoperative 6 hours

    Absolute lymphocyte count will be measured from the complete blood count and reported in ×10^9/L.

  12. Neutrophil-to-Lymphocyte Ratio

    Time frame: Postoperative 6 hours

    The neutrophil-to-lymphocyte ratio will be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. The ratio is unitless.

  13. Intraoperative Heart Rate

    Time frame: From induction of general anesthesia to completion of surgery

    Heart rate will be recorded in beats per minute during the intraoperative period and compared between groups.

  14. Intraoperative Mean Arterial Pressure

    Time frame: From induction of general anesthesia to completion of surgery

    Mean arterial pressure will be recorded in mmHg during the intraoperative period and compared between groups.

Study contacts

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

Fatma Çiğdem ÖZAKIN, MD

CONTACT

[email protected]

+905464168250

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

The Effect of Serratus Anterior Plane Block Timing on Postoperative Quality of Recovery, Postoperative Pain, and Inflammatory Response in Elective Unilateral Mastectomy Surgery: A Prospective Randomized Controlled Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2026
Registry last updated
Jun 22, 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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