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CompletedNCT06419504Updated May 16, 2025

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

An observational study in Breast Cancer, sponsored by Antalya Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by Antalya Training and Research Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
96
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Breast Cancer

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Keywords

  • regional anesthesia
  • postoperative pain
  • recovery quality
  • chronic pain
  • breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 96 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Antalya Training and Research Hospital is the lead sponsor of 102 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

It is planned to include ASA I-III patients between the ages of 18-65 who are planned to undergo breast cancer surgery

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
96 participants (actual)
Patient registry
No

Groups and cohorts

  • SAP block group

    Before the surgery, US-guided SAP block will be performed

    Other: SAP block group

  • PECS II block group

    Before the surgery, US-guided PECS II block will be performed

    Other: PECS II block group

  • ESP block group

    Before the surgery, US-guided ESP blockwill be performed

    Other: ESP block group

  • Control group

    No intervention

    Other: Control group

Interventions

  • OtherSAP block group

    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.

  • OtherPECS II block group

    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.

  • OtherESP block group

    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.

  • OtherControl group

    No intervention

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What researchers measure

Primary outcomes

  1. postoperative opioid consumption

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

    Time frame: 24 hours

Secondary outcomes

  1. recovery quality

    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.

    Time frame: 5 minutes

  2. chronic pain

    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.

    Time frame: 3 months

07

Study locations

1 site
  • University of Health Sciences, Antalya Training and Researh Hospital
    Antalya, Muratpaşa, Turkey
08

References and documents

Publications

  • Wang S, Shi J, Dai Y, Zhang J, Liu Q, Yang P, Zhu N. The effect of different nerve block strategies on the quality of post-operative recovery in breast cancer patients: A randomized controlled study. Eur J Pain. 2024 Jan;28(1):166-173. doi: 10.1002/ejp.2178. Epub 2023 Sep 1. PubMed 37655864 ↗
  • Fujii T, Shibata Y, Akane A, Aoki W, Sekiguchi A, Takahashi K, Matsui S, Nishiwaki K. A randomised controlled trial of pectoral nerve-2 (PECS 2) block vs. serratus plane block for chronic pain after mastectomy. Anaesthesia. 2019 Dec;74(12):1558-1562. doi: 10.1111/anae.14856. Epub 2019 Sep 19. PubMed 31535722 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06419504
Lead sponsor
Antalya Training and Research Hospital
Responsible party
Sponsor
First posted
May 17, 2024
Start date
May 17, 2024
Primary completion
Sep 28, 2024
Completion
Feb 28, 2025
Last update
May 16, 2025

Study contacts

Hafizenur O Atalay, M.D.
principal investigator · University of Health Sciences, Antalya Training and Researh Hospital
Arzu O Karaveli, M.D.
principal investigator · University of Health Sciences, Antalya Training and Researh Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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