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NCT Number: NCT07579650

Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Mastectomy

This study aims to evaluate the effect of serratus posterior superior intercostal plane (SPSIP) block on postoperative pain, opioid consumption, and analgesic requirements in patients undergoing mastectomy and axillary lymph node dissection

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fatma Acil

Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)

Location status: Recruiting

Location contact

Fatma Acil, M.D.

CONTACT

[email protected]

+905337225225

About this study

This study is a prospective, randomized, placebo-controlled, multicenter clinical trial designed to evaluate the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing mastectomy with axillary lymph node dissection. Postoperative pain following breast surgery is often significant and may increase opioid consumption and related adverse effects, highlighting the need for effective regional anesthesia techniques.

The SPSIP block is a novel ultrasound-guided interfascial plane block with emerging evidence in thoracic and chest wall procedures; however, its role in breast surgery remains unclear, particularly in placebo-controlled settings. This study aims to determine whether the SPSIP block provides additional benefit as part of a standardized multimodal analgesia approach.

Participants will be randomly assigned to receive either SPSIP block with local anesthetic or a placebo intervention under identical conditions, with blinding applied to all relevant parties. All patients will receive the same perioperative anesthesia and analgesia protocol.

The results of this study are expected to clarify the clinical value of SPSIP block in breast surgery and contribute to the development of evidence-based postoperative pain management strategies.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients aged 18-65 years
  • ASA physical status I-III
  • Scheduled for elective unilateral mastectomy with axillary lymph node dissection under general anesthesia
  • Able to understand and use the Numeric Rating Scale (NRS) for pain assessment
  • Provided written informed consent

Exclusion criteria

  • Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine)
  • Coagulopathy, thrombocytopenia (<100,000/mm³), or ongoing anticoagulant/antiplatelet therapy that cannot be discontinued
  • Infection or skin lesion at the injection site
  • Planned bilateral surgery or additional major surgical procedures
  • Chronic pain conditions or regular use of opioids, gabapentinoids, or centrally acting analgesics
  • Neurological or psychiatric conditions interfering with pain assessment
  • History of previous major thoracic or chest wall surgery on the same side
  • Pregnancy or breastfeeding
  • Refusal to participate or inability to provide informed consent

Treatment and study plan

SPSIP Block With Bupivacaine

Procedure

Participants will receive an ultrasound-guided SPSIP block using bupivacaine.

SPSIP Block With Saline

Procedure

Participants will receive an ultrasound-guided SPSIP block using normal saline under identical conditions.

Primary outcomes

  1. 24-hour cumulative opioid consumption

    Time frame: 24 hours

    Total opioid consumption within the first 24 hours after surgery, recorded in milligrams.

Secondary outcomes

  1. Static postoperative pain intensity at rest

    Time frame: 0, 1, 2, 6, 12, and 24 hours after surgery

    Postoperative pain intensity at rest will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.

  2. Dynamic postoperative pain intensity during movement

    Time frame: 0, 1, 2, 6, 12, and 24 hours after surgery

    Postoperative pain intensity during movement will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.

  3. Rescue analgesia requirement

    Time frame: Within 24 hours after surgery

    Number of patients requiring rescue analgesia and total rescue analgesic consumption.

  4. Time to first rescue analgesia

    Time frame: Within 24 hours after surgery

    Time from the end of surgery to the first administration of rescue analgesia.

  5. Incidence of postoperative nausea and vomiting (PONV)

    Time frame: Within 24 hours after surgery

    Occurrence of nausea and/or vomiting during the postoperative period.

  6. Quality of Recovery-15 (QoR-15) score

    Time frame: 24 hours after surgery

    Quality of recovery assessed using the QoR-15 questionnaire. Quality of Recovery-15 (QoR-15) questionnaire was used to assess postoperative recovery. The total score ranges from a minimum of 0 to a maximum of 150. A higher score represents a better recovery outcome (0 = extremely poor recovery, 150 = excellent recovery)

  7. Block-related and opioid-related adverse events

    Time frame: Within 24 hours after surgery

    Incidence of adverse events including local anesthetic toxicity, hematoma, infection, and opioid-related side effects.

Study contacts

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

Fatma Acil, M.D.

CONTACT

[email protected]

+905337225225

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study title

Mastectomy and Axillary Dissection: Evaluation of the Effect of Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia: A Multicenter, Randomized, Placebo-Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
Jul 21, 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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