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

NCT06419504 | Completed

• 1 other identifier: 6/11
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

regional anesthesia; postoperative pain; recovery quality; chronic pain; breast cancer

Outcome Measures

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.

  24 hours

Secondary Outcomes (2)

• recovery quality

  5 minutes

• chronic pain

  3 months

Study Arms (4)

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

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.

SAP block group

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.

PECS II block group

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.

ESP block group

Control group OTHER

No intervention

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: The patients scheduled for elective breast surgery (modified radical mastectomy, breast conserving surgery, simple mastectomy, axillary lymph node dissection, etc.)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences, Antalya Training and Researh Hospital

Antalya, Muratpaşa, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 37655864 BACKGROUND

• 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.

  PMID: 31535722 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Chronic Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hafizenur O Atalay, M.D.

  University of Health Sciences, Antalya Training and Researh Hospital

  PRINCIPAL INVESTIGATOR

• Arzu O Karaveli, M.D.

  University of Health Sciences, Antalya Training and Researh Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: May 17, 2024
• Primary Completion: September 28, 2024
• Study Completion: February 28, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)