Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-27 @ 2:37 AM
Study NCT ID:
NCT06911892
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2025-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Sensory Mapping of Regional Anesthesia Techniques in Breast Cancer Surgery
Sponsor:
Samsun University
Organization:
Study Overview
Official Title:
Cutaneous Sensory Mapping and Comparative Analysis of Different Regional Anesthesia Techniques in Breast Cancer Surgeries: A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Various regional anesthesia techniques, either individually or in combination, can be utilized for analgesia in breast cancer surgery. This study aims to map the cutaneous sensory block areas of different regional anesthesia techniques (serratus anterior plane block, parasternal block, and interpectoral + pectoserratus plane block) applied to patients undergoing breast cancer surgery. Furthermore, the extent to which these blocks cover the modified radical mastectomy incision will be assessed. The study seeks to comparatively determine the minimum and maximum sensory spread of each block. Ultimately, the findings are intended to provide valuable data for developing tailored perioperative pain management strategies specific to the surgical procedure and individual patient needs.
Detailed Description:
Breast cancer is the most common type of cancer in women, and surgical intervention is frequently employed as a treatment modality. However, the choice of surgical approach may vary depending on the tumor subtype and the extent of metastasis. The orientation of the surgical incision also differs based on the tumor location and/or the presence of axillary involvement.
Accurately identifying the anatomical location of the affected tissues during breast surgery is of critical importance for planning an effective perioperative analgesia strategy. Procedures such as lumpectomy, partial mastectomy, and therapeutic mammoplasty primarily involve the skin and subcutaneous breast tissue. Depending on whether the surgery is performed medial or lateral to the nipple, the anterior or lateral cutaneous branches of the intercostal nerves play a role in innervating the surgical area. In more extensive surgeries such as modified radical mastectomy (MRM), nerves originating from the brachial plexus (pectoralis, thoracodorsal, and long thoracic nerves) may contribute to perioperative pain. These procedures typically involve the dissection of all subcutaneous breast tissue, the overlying skin, and the pectoralis and serratus anterior muscles and often necessitate sentinel lymph node biopsy or axillary dissection.
Due to these factors, various incision types are used in oncological breast surgeries depending on the type of surgery. Therefore, a patient-specific perioperative pain protocol should be established for each procedure, and the most appropriate regional anesthesia technique should be selected accordingly.
In the literature, serratus plane blocks, paravertebral block, interpectoral, and pectoserratus blocks, as well as their combination, have been reported to provide effective perioperative pain management in breast cancer surgery. These techniques offer benefits such as reducing acute and chronic pain, minimizing the surgical stress response, facilitating early mobilization, decreasing opioid consumption, and ensuring a more hemodynamically stable perioperative period.
In the investigators' clinic, regional anesthesia techniques guided by ultrasound are routinely administered, either alone or in combination, to manage perioperative pain in patients undergoing breast cancer surgery. These techniques include serratus anterior plane block, parasternal block, and interpectoral + pectoserratus plane block.
The study was designed as an observational clinical trial to evaluate patients undergoing breast cancer surgery who received regional anesthesia for perioperative pain management. The primary objective is to evaluate the cutaneous sensory block areas of these blocks and compare the blocked sensory areas with the modified radical mastectomy incision to assess the minimum and maximum sensory spread of each block.
Accurately identifying the anatomical location of the affected tissues during breast surgery is of critical importance for planning an effective perioperative analgesia strategy. Procedures such as lumpectomy, partial mastectomy, and therapeutic mammoplasty primarily involve the skin and subcutaneous breast tissue. Depending on whether the surgery is performed medial or lateral to the nipple, the anterior or lateral cutaneous branches of the intercostal nerves play a role in innervating the surgical area. In more extensive surgeries such as modified radical mastectomy (MRM), nerves originating from the brachial plexus (pectoralis, thoracodorsal, and long thoracic nerves) may contribute to perioperative pain. These procedures typically involve the dissection of all subcutaneous breast tissue, the overlying skin, and the pectoralis and serratus anterior muscles and often necessitate sentinel lymph node biopsy or axillary dissection.
Due to these factors, various incision types are used in oncological breast surgeries depending on the type of surgery. Therefore, a patient-specific perioperative pain protocol should be established for each procedure, and the most appropriate regional anesthesia technique should be selected accordingly.
In the literature, serratus plane blocks, paravertebral block, interpectoral, and pectoserratus blocks, as well as their combination, have been reported to provide effective perioperative pain management in breast cancer surgery. These techniques offer benefits such as reducing acute and chronic pain, minimizing the surgical stress response, facilitating early mobilization, decreasing opioid consumption, and ensuring a more hemodynamically stable perioperative period.
In the investigators' clinic, regional anesthesia techniques guided by ultrasound are routinely administered, either alone or in combination, to manage perioperative pain in patients undergoing breast cancer surgery. These techniques include serratus anterior plane block, parasternal block, and interpectoral + pectoserratus plane block.
The study was designed as an observational clinical trial to evaluate patients undergoing breast cancer surgery who received regional anesthesia for perioperative pain management. The primary objective is to evaluate the cutaneous sensory block areas of these blocks and compare the blocked sensory areas with the modified radical mastectomy incision to assess the minimum and maximum sensory spread of each block.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: