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

Completed

• Conditions: Breast Cancer
• Interventions: Other: PECS II block group; Other: Control group; Other: SAP block group; Other: ESP block group

• Registration Number: NCT06419504
• Lead Sponsor: Antalya Training and Research Hospital

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.

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.

Study Timeline

• Study First Submitted: 2024-05-14
• Study Start: 2024-05-17
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-17
• Primary Completion: 2024-09-28
• Study Completion: 2025-02-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PECS II block group	PECS II block group	Before the surgery, US-guided PECS II block will be performed
Control group	Control group	No intervention
SAP block group	SAP block group	Before the surgery, US-guided SAP block will be performed
ESP block group	ESP block group	Before the surgery, US-guided ESP blockwill be performed

Primary Outcome Measures

Name	Time	Method
postoperative opioid consumption	24 hours	All patients will receive a standard patient controlled analgesia (PCA) protocol. The postoperative opioid consumption will only be recorded.

Secondary Outcome Measures

Name	Time	Method
recovery quality	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.
chronic pain	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.

Trial Locations

Locations (1)

University of Health Sciences, Antalya Training and Researh Hospital; 🇹🇷 Antalya, Muratpaşa, Turkey