Clinical trial NCT06911892: Comparative Sensory Mapping of Regional Anesthesia Techniques in Breast Cancer Surgery
Official title: Cutaneous Sensory Mapping and Comparative Analysis of Different Regional Anesthesia Techniques in Breast Cancer Surgeries: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Pain, Postoperative
Keywords: Regional Anesthesia
Pain Management
Cutaneous Sensory Mapping
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for breast cancer surgery and receiving regional anesthesia as part of their perioperative analgesia management will be included in the study.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with unilateral breast cancer surgery
* Patients receiving regional anesthesia as part of their perioperative analgesia management
* Aged between 18 and 65 years.
* ASA\<IV
* Patients who agree to participate and provide written informed consent

Exclusion Criteria:

* Patients who refuse to participate.
* Patients who have not undergone any regional anesthesia technique.
* ASA\>III
* Bilateral mastectomy.
* History of previous breast surgery (except excisional biopsy).
* Cognitive impairment or dementia.
* Patients with psychiatric disorders such as depression, mania, or schizophrenia.

Primary outcomes:
measure: Cutaneous sensory block area mapping for different regional anesthesia techniques in breast cancer surgery
timeFrame: At 30 minutes after the regional anesthesia and before surgery
Secondary outcomes:
measure: Determination of the minimum and maximum spread of each block technique in relation to the modified radical mastectomy (MRM) incision
timeFrame: At 30 minutes after the regional anesthesia and before surgery
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University, Samsun Training and Research Hospital
state: Ilkadim
Study officials:
affiliation: Samsun University
name: Caner Genc, M.D.
role: STUDY_DIRECTOR
References:
citation: FitzGerald S, Odor PM, Barron A, Pawa A. Breast surgery and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):95-110. doi: 10.1016/j.bpa.2019.03.003. Epub 2019 Apr 6.
citation: Hargrave J, Grant MC, Kolarczyk L, Kelava M, Williams T, Brodt J, Neelankavil JP. An Expert Review of Chest Wall Fascial Plane Blocks for Cardiac Surgery. J Cardiothorac Vasc Anesth. 2023 Feb;37(2):279-290. doi: 10.1053/j.jvca.2022.10.026. Epub 2022 Nov 1.
citation: Jacobs A, Lemoine A, Joshi GP, Van de Velde M, Bonnet F; PROSPECT Working Group collaborators#. PROSPECT guideline for oncological breast surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2020 May;75(5):664-673. doi: 10.1111/anae.14964. Epub 2020 Jan 26.