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NCT Number: NCT06711549

"Serratus Anterior Plane Block" Versus "Serratus Posterior Superior Plane Intercostal Plane Block" for Patients Undergoing Breast Surgery

The Serrato Posterosuperior Block (SPSIP) is a recently discovered technique that provides analgesia to the hemithorax, shoulders, neck and back. At an anatomical level, it has been seen that this technique allows the diffusion of local anesthetic starting from C7 proceeding dorsally up to T10 by sectioning the trapezius, latissimus dorsi, rhomboid and erector spinae muscles. The serratus anterior block (SAPB) is a technique that allows local anesthetic to be injected between the serratus anterior muscle and the intercostal muscles (deep plane) or between the latissimus dorsi muscle and the serratus anterior muscle (superficial plane), also providing analgesia at of the chest wall. This study aims to compare the analgesic efficacy of SPSIPB and SAPB in patients undergoing radical mastectomy for breast cancer

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Key information

Conditions

Pain, Postoperative Anesthesia Breast Cancer Breast Diseases Breast Neoplasms Mastectomy Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult Patient ( > 18 years)
  • Informed consent
  • American Society of Anaesthesiologis Phisical Status I to III
  • Patients undergoing for mastectomy with sentinel lynphnode byopsy/axillary clearence

Exclusion criteria

  • Pregnant women
  • Allergy to any drug present in the protocol

Treatment and study plan

Serratus Posterior Superior Plane Intercostal Plane block

Procedure

Under ultrasound guidance; local anesthetic will be injected in the plane between the posterior aspect of the serratus posterior superior plane and the ribs

Serratus Anterior Plane Block

Procedure

Under ultrasound guidance; local anesthetic will be injected in the plane between the posterior aspect of the serratus anterior and the external intercostal muscles and ribs

Primary outcomes

  1. Pain at 0 hours after surgery

    Time frame: 0 hours after surgery

    The primary objective of the study is to evaluate whether there is a difference between SAP block and SPSIP block at 0 hours after surgery at rest measure with visual analogic scale (0-10)

Secondary outcomes

  1. Pain at 6 hours after surgery

    Time frame: 6 hours after surgery

    Evaluate whether there is a difference between SAP block and SPSIP block at 6 hours after surgery at rest measure with visual analogic scale (0-10)

  2. Pain at 12 hours after surgery

    Time frame: 12 hours after surgery

    Evaluate whether there is a difference between SAP block and SPSIP block at 12 hours after surgery at rest measure with visual analogic scale (0-10)

  3. Pain at 24hours after surgery

    Time frame: 24 hours after surgery

    Evaluate whether there is a difference between SAP block and SPSIP block at 24 hours after surgery at rest measure with visual analogic scale (0-10)

  4. Intraoperative Opioid consumption

    Time frame: During the surgery(From patient intubation to patient extubation)

    Intraoperative opioids consumption (remifentanyl measured as mcg/kg)

  5. Postoperative Opioid consumption

    Time frame: From extubation to 24 hours post-enrollment

    Postoperative use of rescue analgesics (measured as yes or no)

  6. Postoperative Nausea and Vomiting

    Time frame: From extubation to 24 hours post-enrollment

    Postoperative Nausea and Vomiting defined as patient reporting nausea and vomiting or requiring drugs for nausea or vomiting

Study contacts

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

Valentina Scaduto

CONTACT

[email protected]

3272217089 ext. +390499424898

Sponsors and collaborators

Lead sponsor

Ospedale di Camposampiero

Other

Collaborators

  • Azienda Ulss 6 Euganea

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

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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