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NCT Number: NCT06419504

The Effect of Ultrasonography-guided Fascial Plane Blocks in Breast Cancer Surgery Patients

The aim of this study was to evaluate the efficacy of serratus anterior plane (SAP) block, pectoserratus plane (PECS II) block, and erector spinae plane (ESP) block on postoperative acute pain, quality of recovery and chronic pain in breast cancer surgery patients.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Health Sciences, Antalya Training and Researh Hospital

Antalya, Muratpaşa, Turkey (Türkiye)

About this study

Breast cancer is the most common type of cancer in women. Although surgical treatment is effective and curative, it is associated with many complications in the postoperative period. Acute pain after surgery is one of them. Approximately half of women undergoing breast surgery describe significant post-operative pain (>5 on the Visual Analogue Scale; VAS) score that is not always effectively controlled by standard post-operative treatments. Poorly controlled postoperative pain has been associated with impaired functional recovery, delayed discharge from the post-anesthetic care unit, and prolonged hospital stay. In addition, poorly managed acute pain becomes chronic and is described as 'post-mastectomy pain syndrome'. Regional techniques can reduce acute and chronic postoperative pain. The development of ultrasonography (US)-guided regional anesthesia has led to the development of fascial plane blocks. Serratus anterior plan (SAP) block, pectoserratus plan (PECS II) block, and erector spina plan (ESP) block are frequently used for postoperative analgesia in patients undergoing breast surgery. he aim of this study was to evaluate the efficacy of serratus anterior plane (SAP) block, pectoserratus plane (PECS II) block, and erector spinae plane (ESP) block on postoperative acute pain, quality of recovery and chronic pain in breast cancer surgery patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • elective breast surgery (modified radical mastectomy, breast conserving surgery, simple mastectomy, axillary lymph node dissection, etc.),
  • 18 to 65 years old,
  • American Society of Anaesthesiology (ASA) score I-III
  • body mass index (BMI) <32 kg/m2

Exclusion criteria

  • contraindications to the block applications
  • history of mental or neurological disorders
  • history of chronic opioid use
  • chronic alcoholism
  • substance use
  • treatment of chronic pain
  • severe liver and kidney disease
  • uncooperative patients
  • patients scheduled for bilateral mastectomy

Treatment and study plan

SAP block group

Other

US-guided SAP block is performed approximately 30 minutes before the surgery in patients undergoing breast cancer surgery in a separate regional anesthesia room with standard anesthesia monitoring.

PECS II block group

Other

US-guided PECS II block is performed approximately 30 minutes before the surgery in patients undergoing breast cancer surgery in a separate regional anesthesia room with standard anesthesia monitoring.

ESP block group

Other

US-guided ESP block is performed approximately 30 minutes before the surgery in patients undergoing breast cancer surgery in a separate regional anesthesia room with standard anesthesia monitoring.

Control Group

Other

No intervention

Primary outcomes

  1. postoperative opioid consumption

    Time frame: 24 hours

    All patients will receive a standard patient controlled analgesia (PCA) protocol. The postoperative opioid consumption will only be recorded.

Secondary outcomes

  1. recovery quality

    Time frame: 5 minutes

    The Quality of Recovery-15 (QoR-15) is a 15-question questionnaire validated to assess poetoperative recovery. This questionnaire assesses patients' pain, physical comfort, physical independence, psychological support, and emotional status in the erly postoperative period. The patient is asked to express their status scoring from 0 to 10; therefore, the total score ranges from 0 to 150 points.

  2. chronic pain

    Time frame: 3 months

    Patients will be telephoned 3 months after the operation and the presence, localization, and intensity of the pain, its character, and its relation with rest and/or activity will be recorded by asking only verbally.

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

The Effect of Ultrasonography-guided Pectoserratus Plane Block, Erector Spina Plane Block and Serratus Anterior Plane Block on Postoperative Opioid Consumption, Recovery Quality and Chronic Pain in Breast Cancer Surgery Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 17, 2024
Registry last updated
May 16, 2025

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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