Breast CancerNCT06419504
The Effect of Ultrasonography-guided Fascial Plane Blocks in Breast Cancer Surgery Patients
An observational study of Breast Cancer, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SAP block group, PECS II block group and ESP block group
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 May 2024to 28 Feb 2025
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- contraindications to the block applications
- history of mental or neurological disorders
- history of chronic opioid use
- chronic alcoholism
- substance use
- treatment of chronic pain
Show all 9Show fewer
- severe liver and kidney disease
- uncooperative patients
- patients scheduled for bilateral mastectomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Antalya Training and Researh Hospital
Antalya, Muratpaşa
About this study
Official title: The Effect of Ultrasonography-guided Pectoserratus Plane Block, Erector Spina Plane Block and Serratus Anterior Plane Block on Postoperative Opioid Consumption, Recovery Quality and Chronic Pain in Breast Cancer Surgery Patients
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- SAP block group, PECS II block group, ESP block group, Control group
- Keywords
- regional anesthesia, postoperative pain, recovery quality, chronic pain, breast cancer
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAP block groupOther
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.
PECS II block groupOther
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.
ESP block groupOther
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.
Control groupOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| SAP block group | Before the surgery, US-guided SAP block will be performed Receives: Other: SAP block group | |
| PECS II block group | Before the surgery, US-guided PECS II block will be performed Receives: Other: PECS II block group | |
| ESP block group | Before the surgery, US-guided ESP blockwill be performed Receives: Other: ESP block group | |
| Control group | No intervention Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid consumption
All patients will receive a standard patient controlled analgesia (PCA) protocol. The postoperative opioid consumption will only be recorded.
Measured: 24 hours
Secondary outcomes (2)
recovery quality
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.
Measured: 5 minutes
chronic pain
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start17 May 2024
- Primary completion28 Sep 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Case only
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hafizenur O Atalay, M.D., Principal investigator, University of Health Sciences, Antalya Training and Researh HospitalArzu O Karaveli, M.D., Principal investigator, University of Health Sciences, Antalya Training and Researh Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419504
- Sponsor's protocol ID
- 6/11
- Status last verified
- May 2025
- First submitted
- 14 May 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37655864Fujii 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.
PubMed 31535722
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasonography-guided Pectoserratus Plane Block, Erector Spina Plane Block and Serratus Anterior Plane Block on Postoperative Opioid Consumption, Recovery Quality and Chronic Pain in Breast Cancer Surgery Patients
- ClinicalTrials.gov ID
- NCT06419504
- Acronym / sponsor ID
- 6/11
- Conditions
- Breast Cancer
- Keywords
- regional anesthesia, postoperative pain, recovery quality, chronic pain, breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 17 May 2024 (actual)
- Primary completion
- 28 Sep 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 17 May 2024 (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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAP block group | – | Other: SAP block groupBefore the surgery, US-guided SAP block will be performed |
| PECS II block group | – | Other: PECS II block groupBefore the surgery, US-guided PECS II block will be performed |
| ESP block group | – | Other: ESP block groupBefore the surgery, US-guided ESP blockwill be performed |
| Control group | – | Other: Control groupNo intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- contraindications to the block applications
- history of mental or neurological disorders
- history of chronic opioid use
- chronic alcoholism
- substance use
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 |
|---|---|---|
| SAP block groupUS-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. | Other | SAP block group |
| PECS II block groupUS-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. | Other | PECS II block group |
| ESP block groupUS-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. | Other | ESP block group |
| Control groupNo intervention | Other | Control group |
Primary outcome
postoperative opioid consumption
Time frame: 24 hours
All patients will receive a standard patient controlled analgesia (PCA) protocol. The postoperative opioid consumption will only be recorded.
2 secondary outcomes
recovery quality
Time frame: 5 minutes
chronic pain
Time frame: 3 months
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 16 May 2025.
- Background: PubMed 37655864Wang 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.
- Background: PubMed 31535722Fujii 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.
- Individual participant dataSharing planned: No
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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.
Hafizenur O Atalay, M.D. principal investigator
University of Health Sciences, Antalya Training and Researh Hospital
Arzu O Karaveli, M.D. principal investigator
University of Health Sciences, Antalya Training and Researh Hospital
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, run by Antalya Training and Research Hospital 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 4 inclusion and 9 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 16 May 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?
postoperative opioid consumption (time frame: 24 hours). 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 NCT06419504, which also lists 2 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 16 May 2025.