Breast CancerNCT06911892
Comparative Sensory Mapping of Regional Anesthesia Techniques in Breast Cancer Surgery
An observational study of Breast Cancer and Pain, Postoperative, run by Samsun University at 1 site in Turkey (Türkiye).
Trial 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 +… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Pain, Postoperative
- What is being tested?
- Group Serratus Anterior Plane Block, Group Parasternal Block and Group Interpectoral+Pectoserratus Plane Block
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2025to 24 Oct 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with unilateral breast cancer surgery
- Patients receiving regional anesthesia as part of their perioperative analgesia management
- Aged between 18 and 70 years.
- ASA<IV
- Patients who agree to participate and provide written informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun University, Samsun Training and Research Hospital
Samsun, Ilkadim, 55400
About this study
Official title: Cutaneous Sensory Mapping and Comparative Analysis of Different Regional Anesthesia Techniques in Breast Cancer Surgeries: A Prospective Observational Study
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.
Read the 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.
- Conditions
- Breast Cancer, Pain, Postoperative
- Being tested
- Group Serratus Anterior Plane Block, Group Parasternal Block, Group Interpectoral+Pectoserratus Plane Block
- Keywords
- Regional Anesthesia, Pain Management, Cutaneous Sensory Mapping
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Serratus Anterior Plane BlockOther
Patients will receive a serratus anterior plane block preoperatively under ultrasound guidance. Thirty minutes after the block, the cutaneous sensory area will be assessed using a pinprick test and outlined on the skin using a UV marker. Subsequently, the incision line for the modified radical mastectomy (MRM) will be marked by the operating surgeon. The resulting drawings will be documented and transferred to a digital template for analysis.
Group Parasternal BlockOther
Patients will receive a parasternal block preoperatively under ultrasound guidance. Thirty minutes after the block, the cutaneous sensory area will be assessed using a pinprick test and outlined on the skin using a UV marker. Subsequently, the incision line for the modified radical mastectomy (MRM) will be marked by the operating surgeon. The resulting drawings will be documented and transferred to a digital template for analysis.
Group Interpectoral+Pectoserratus Plane BlockOther
Patients will receive an interpectoral + pectoserratus plane block preoperatively under ultrasound guidance.
Thirty minutes after the block, the cutaneous sensory area will be assessed using a pinprick test and outlined on the skin using a UV marker. Subsequently, the incision line for the modified radical mastectomy (MRM) will be marked by the operating surgeon. The resulting drawings will be documented and transferred to a digital template for analysis.
| Study group | Role | What they receive |
|---|---|---|
| Group Serratus Anterior Plane Block | Patients who received ultrasound-guided Serratus Anterior Plane Block during the preoperative period. Receives: Other: Group Serratus Anterior Plane Block | |
| Group Parasternal Block | Patients who received ultrasound-guided Parasternal Block during the preoperative period. Receives: Other: Group Parasternal Block | |
| Group Interpectoral+Pectoserratus Plane Block | Patients who received ultrasound-guided Interpectoral+Pectoserratus Plane Block during the preoperative period. Receives: Other: Group Interpectoral+Pectoserratus Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous sensory block area mapping for different regional anesthesia techniques in breast cancer surgery
The cutaneous sensory block area resulting from the regional anesthesia technique applied to each patient will be assessed using a pinprick test at the 30th minute post-block. These areas will be delineated and mapped using a UV marker, and the data collected for each group will be processed to generate a density map using the digital template.
Measured: At 30 minutes after the regional anesthesia and before surgery
Secondary outcomes (1)
Determination of the minimum and maximum spread of each block technique in relation to the modified radical mastectomy (MRM) incision
The cutaneous sensory block area following the regional anesthesia technique will be compared with the modified radical mastectomy (MRM) incision indicated by the surgeon on the patient. The images will be documented and analyzed with digital template. Areas that correspond (either fully or partially) with the incision line will be identified. For each block technique, the minimum and maximum spread of the modified radical mastectomy (MRM) incision will be determined and compared.
Measured: At 30 minutes after the regional anesthesia and before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start14 Apr 2025
- Primary completion14 Oct 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caner Genc, M.D., Study director, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911892
- Sponsor's protocol ID
- GOKAEK 2025/6/11
- Status last verified
- Nov 2025
- First submitted
- 28 Mar 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31272657Hargrave 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.
PubMed 36414532Jacobs 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.
PubMed 31984479
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutaneous Sensory Mapping and Comparative Analysis of Different Regional Anesthesia Techniques in Breast Cancer Surgeries: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06911892
- Acronym / sponsor ID
- GOKAEK 2025/6/11
- Conditions
- Breast Cancer, Pain, Postoperative
- Keywords
- Regional Anesthesia, Pain Management, Cutaneous Sensory Mapping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 14 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Serratus Anterior Plane Block | – | Other: Group Serratus Anterior Plane BlockPatients who received ultrasound-guided Serratus Anterior Plane Block during the preoperative period. |
| Group Parasternal Block | – | Other: Group Parasternal BlockPatients who received ultrasound-guided Parasternal Block during the preoperative period. |
| Group Interpectoral+Pectoserratus Plane Block | – | Other: Group Interpectoral+Pectoserratus Plane BlockPatients who received ultrasound-guided Interpectoral+Pectoserratus Plane Block during the preoperative period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Patients with unilateral breast cancer surgery
- Patients receiving regional anesthesia as part of their perioperative analgesia management
- Aged between 18 and 70 years.
- ASA<IV
- Patients who agree to participate and provide written informed consent
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Serratus Anterior Plane BlockPatients will receive a serratus anterior plane block preoperatively under ultrasound guidance. Thirty minutes after the block, the cutaneous sensory area will be assessed using a pinprick test and outlined on the skin using a UV marker. Subsequently, the incision line for the modified radical mastectomy (MRM) will be marked by the operating surgeon. The resulting drawings will be documented and transferred to a digital template for analysis. | Other | Group Serratus Anterior Plane Block |
| Group Parasternal BlockPatients will receive a parasternal block preoperatively under ultrasound guidance. Thirty minutes after the block, the cutaneous sensory area will be assessed using a pinprick test and outlined on the skin using a UV marker. Subsequently, the incision line for the modified radical mastectomy (MRM) will be marked by the operating surgeon. The resulting drawings will be documented and transferred to a digital template for analysis. | Other | Group Parasternal Block |
| Group Interpectoral+Pectoserratus Plane BlockPatients will receive an interpectoral + pectoserratus plane block preoperatively under ultrasound guidance. Thirty minutes after the block, the cutaneous sensory area will be assessed using a pinprick test and outlined on the skin using a UV marker. Subsequently, the incision line for the modified radical mastectomy (MRM) will be marked by the operating surgeon. The resulting drawings will be documented and transferred to a digital template for analysis. | Other | Group Interpectoral+Pectoserratus Plane Block |
Primary outcome
Cutaneous sensory block area mapping for different regional anesthesia techniques in breast cancer surgery
Time frame: At 30 minutes after the regional anesthesia and before surgery
The cutaneous sensory block area resulting from the regional anesthesia technique applied to each patient will be assessed using a pinprick test at the 30th minute post-block. These areas will be delineated and mapped using a UV marker, and the data collected for each group will be processed to generate a density map using the digital template.
1 secondary outcome
Determination of the minimum and maximum spread of each block technique in relation to the modified radical mastectomy (MRM) incision
Time frame: At 30 minutes after the regional anesthesia and before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 31272657FitzGerald 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.
- Background: PubMed 36414532Hargrave 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.
- Background: PubMed 31984479Jacobs 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caner Genc, M.D. study director
Samsun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Pain, Postoperative, run by Samsun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous sensory block area mapping for different regional anesthesia techniques in breast cancer surgery (time frame: At 30 minutes after the regional anesthesia and before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06911892, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.