Pain, PostoperativeNCT05961735
Comparison of PECS II Block and Combined Serratus Anterior Plane Block to Reduce Acute Pain After Mastectomy
An observational study of Pain, Postoperative, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, PECS II block or CSAB will be applied to patients who have had a modified radical mastectomy under general anesthesia for postoperative pain relief by using 30 ml of 0.25% bupivacaine .All patients will receive tramadol with a patient-controlled analgesia device during the postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- PECS II Block and Combined Serratus Anterior Plane Block
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Jun 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who undergone mastectomy surgery
Who may be able to join
- Patients between the ages of 18-80
- Patients with ASA score I-II-III
- Patients with a body mass index (BMI) between 18 and 40
- Patients who underwent PECS-II block or CSAB with mastectomy in the operating room
Who cannot join
- Patients under the age of 18 and over the age of 80
- Patients with an ASA score of IV and above
- Patients with advanced co-morbidity
- Patients with a history of bleeding diathesis
- Patients who have infection in the area which is to be blocked
- BMI below 18 and over 40
- Patients undergoing emergency surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170
About this study
In this study, PECS II block or CSAB will be applied to patients who have had a modified radical mastectomy under general anesthesia for postoperative pain relief by using 30 ml of 0.25% bupivacaine .All patients will receive tramadol with a patient-controlled analgesia device during the postoperative period. Pain, nausea-vomiting, additional analgesic and antiemetic drug requirement, within 24 hours postoperatively will be compared between groups.
In this study, it was aimed to compare the efficacy of both peripheral nerve block methods in patients after mastectomy.
Read the detailed description
Breast cancer ranks first among the most common malignant neoplasms in women. Surgery has been a mainstay of breast cancer treatment for several decades and historically, a modified radical mastectomy was the primary method of treatment for breast cancer. Poorly controlled acute postoperative pain is associated with increased morbidity, functional and quality-of-life impairment. Additionally, severe acute postoperative pain is found to be a risk factor for chronic pain.
Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abirritation during modified radical mastectomy, but their application is limited due to the complex nature of the procedures and serious complications. There is growing interest in the pectoralis nerve (PECS) blocks and serratus anterior block (SAB) which are less invasive as an analgesic technique during breast surgeries to reduce postoperative pain.
The Pecs I block is a single injection of local anaesthetic between pectoralis major and pectoralis minor muscles at the level of the 3rd rib to anaesthetise the lateral and medial pectoral nerves. The Pecs II block is a modified Pecs I block and can be achieved with one needle insertion point. Local anaesthetic is placed between pectorals major and minor as for a Pecs I block and then between pectoralis minor and serratus anterior muscles.
Numerous clinical studies focusing on the analgesic potential of PECS block in breast augmentation surgery, small breast surgery and breast cancer surgery have yielded positive results. SAD is more superficial, easy to access and less likely to have complications like PECS block. SAPB can be implemented in two ways. Deep SAB (DSAB) is applied under the serratus anterior muscle, while superficial SAB (YSAB) is applied over the serratus anterior muscle. In recent years, deep and superficial SAB, that is, combined SAB (CSAB), has been started to be applied in order to increase the effect area of local anesthetics and to prevent block failure.
In this study, PECS II block or CSAB will be applied to patients who have had a modified radical mastectomy under general anesthesia for postoperative pain relief by using 30 ml of 0.25% bupivacaine .All patients will receive tramadol with a patient-controlled analgesia device during the postoperative period. Pain, nausea-vomiting, additional analgesic and antiemetic drug requirement, within 24 hours postoperatively will be compared between groups.
In this study, it was aimed to compare the efficacy of both peripheral nerve block methods in patients after mastectomy.
- Conditions
- Pain, Postoperative
- Being tested
- PECS II Block, Combined Serratus Anterior Plane Block
- Keywords
- PECS II Block, Combined Serratus Anterior Plane Block, Mastectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECS II BlockOther
The Pecs II block is applied to the patients after induction of anesthesia .
Combined Serratus Anterior Plane BlockOther
Combined Serratus Anterior Plane Block is applied to the patients after induction of anesthesia .
| Study group | Role | What they receive |
|---|---|---|
| Patients with PECS II Block | PECS 2 block will be applied to patients in this group. Receives: Other: PECS II Block | |
| Patients with Combined Serratus Anterior Plane Block | Combined Serratus Anterior Plane Block will be applied to patients in this group. Receives: Other: Combined Serratus Anterior Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on the Numeric Rating Scale (NRS)
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Measured: 0 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Measured: 2 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Measured: 4 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Measured: 8 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Measured: 12 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Measured: 24 hours postoperatively
Total opioid consumption
All patients will receive tramadol with a patient-controlled analgesia device during the postoperative period.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Aug 2023
- Primary completion1 Nov 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yusuf Özgüner, Ankara Etlik City Hospital
- Investigators
- Yusuf Ozguner, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961735
- Sponsor's protocol ID
- AnkaraEtlikYusufOzguner004
- Status last verified
- Apr 2025
- First submitted
- 14 Jul 2023
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maranto CJ, Strickland NR, Goree JH. Combined Superficial and Deep Serratus Plane Block With Bupivacaine, Dexamethasone, and Clonidine in the Treatment of a Patient With Postmastectomy Pain Syndrome: A Case Report. A A Pract. 2018 Nov 1;11(9):236-237. doi: 10.1213/XAA.0000000000000792.
PubMed 29794801Zhao J, Han F, Yang Y, Li H, Li Z. Pectoral nerve block in anesthesia for modified radical mastectomy: A meta-analysis based on randomized controlled trials. Medicine (Baltimore). 2019 May;98(18):e15423. doi: 10.1097/MD.0000000000015423.
PubMed 31045802Grape S, Jaunin E, El-Boghdadly K, Chan V, Albrecht E. Analgesic efficacy of PECS and serratus plane blocks after breast surgery: A systematic review, meta-analysis and trial sequential analysis. J Clin Anesth. 2020 Aug;63:109744. doi: 10.1016/j.jclinane.2020.109744. Epub 2020 Feb 25.
PubMed 32109825Ozguner Y, Yazar CO, Aydin F, Zengin M, Arik E, Kotanoglu MS, Altinsoy S, Ergil J. Comparison of the analgesic efficacy of combined superficial and deep serratus anterior plane block versus pectoserratus plane block following modified radical mastectomy surgery. BMC Anesthesiol. 2025 Jul 28;25(1):358. doi: 10.1186/s12871-025-03213-9.
PubMed 40721998
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of PECS II Block and Combined Serratus Anterior Plane Block to Reduce Acute Pain After Mastectomy
- ClinicalTrials.gov ID
- NCT05961735
- Acronym / sponsor ID
- AnkaraEtlikYusufOzguner004
- Conditions
- Pain, Postoperative
- Keywords
- PECS II Block, Combined Serratus Anterior Plane Block, Mastectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 27 Jul 2023 (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.
In this study, PECS II block or CSAB will be applied to patients who have had a modified radical mastectomy under general anesthesia for postoperative pain relief by using 30 ml of 0.25% bupivacaine .All patients will receive tramadol with a patient-controlled analgesia device during the postoperative period. Pain, nausea-vomiting, additional analgesic and antiemetic drug requirement, within 24 hours postoperatively will be compared between groups.
In this study, it was aimed to compare the efficacy of both peripheral nerve block methods in patients after mastectomy.
Detailed description
Breast cancer ranks first among the most common malignant neoplasms in women. Surgery has been a mainstay of breast cancer treatment for several decades and historically, a modified radical mastectomy was the primary method of treatment for breast cancer. Poorly controlled acute postoperative pain is associated with increased morbidity, functional and quality-of-life impairment. Additionally, severe acute postoperative pain is found to be a risk factor for chronic pain.
Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abirritation during modified radical mastectomy, but their application is limited due to the complex nature of the procedures and serious complications. There is growing interest in the pectoralis nerve (PECS) blocks and serratus anterior block (SAB) which are less invasive as an analgesic technique during breast surgeries to reduce postoperative pain.
The Pecs I block is a single injection of local anaesthetic between pectoralis major and pectoralis minor muscles at the level of the 3rd rib to anaesthetise the lateral and medial pectoral nerves. The Pecs II block is a modified Pecs I block and can be achieved with one needle insertion point. Local anaesthetic is placed between pectorals major and minor as for a Pecs I block and then between pectoralis minor and serratus anterior muscles.
Numerous clinical studies focusing on the analgesic potential of PECS block in breast augmentation surgery, small breast surgery and breast cancer surgery have yielded positive results. SAD is more superficial, easy to access and less likely to have complications like PECS block. SAPB can be implemented in two ways. Deep SAB (DSAB) is applied under the serratus anterior muscle, while superficial SAB (YSAB) is applied over the serratus anterior muscle. In recent years, deep and superficial SAB, that is, combined SAB (CSAB), has been started to be applied in order to increase the effect area of local anesthetics and to prevent block failure.
In this study, PECS II block or CSAB will be applied to patients who have had a modified radical mastectomy under general anesthesia for postoperative pain relief by using 30 ml of 0.25% bupivacaine .All patients will receive tramadol with a patient-controlled analgesia device during the postoperative period. Pain, nausea-vomiting, additional analgesic and antiemetic drug requirement, within 24 hours postoperatively will be compared between groups.
In this study, it was aimed to compare the efficacy of both peripheral nerve block methods in patients after mastectomy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with PECS II Block | – | Other: PECS II BlockPECS 2 block will be applied to patients in this group. |
| Patients with Combined Serratus Anterior Plane Block | – | Other: Combined Serratus Anterior Plane BlockCombined Serratus Anterior Plane Block will be applied to patients in this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who undergone mastectomy surgery
Key inclusion criteria (4 listed)
- Patients between the ages of 18-80
- Patients with ASA score I-II-III
- Patients with a body mass index (BMI) between 18 and 40
- Patients who underwent PECS-II block or CSAB with mastectomy in the operating room
Key exclusion criteria (7 listed)
- Patients under the age of 18 and over the age of 80
- Patients with an ASA score of IV and above
- Patients with advanced co-morbidity
- Patients with a history of bleeding diathesis
- Patients who have infection in the area which is to be blocked
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 |
|---|---|---|
| PECS II BlockThe Pecs II block is applied to the patients after induction of anesthesia . | Other | Patients with PECS II Block |
| Combined Serratus Anterior Plane BlockCombined Serratus Anterior Plane Block is applied to the patients after induction of anesthesia . | Other | Patients with Combined Serratus Anterior Plane Block |
Primary outcome
Pain on the Numeric Rating Scale (NRS)
Time frame: 0 hours postoperatively
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Pain on the Numeric Rating Scale (NRS)
Time frame: 2 hours postoperatively
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Pain on the Numeric Rating Scale (NRS)
Time frame: 4 hours postoperatively
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Pain on the Numeric Rating Scale (NRS)
Time frame: 8 hours postoperatively
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Pain on the Numeric Rating Scale (NRS)
Time frame: 12 hours postoperatively
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Pain on the Numeric Rating Scale (NRS)
Time frame: 24 hours postoperatively
Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.
Total opioid consumption
Time frame: 24 hours postoperatively
All patients will receive tramadol with a patient-controlled analgesia device during the postoperative period.
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 11 Apr 2025.
- Results publication: PubMed 29794801Maranto CJ, Strickland NR, Goree JH. Combined Superficial and Deep Serratus Plane Block With Bupivacaine, Dexamethasone, and Clonidine in the Treatment of a Patient With Postmastectomy Pain Syndrome: A Case Report. A A Pract. 2018 Nov 1;11(9):236-237. doi: 10.1213/XAA.0000000000000792.
- Results publication: PubMed 31045802Zhao J, Han F, Yang Y, Li H, Li Z. Pectoral nerve block in anesthesia for modified radical mastectomy: A meta-analysis based on randomized controlled trials. Medicine (Baltimore). 2019 May;98(18):e15423. doi: 10.1097/MD.0000000000015423.
- Results publication: PubMed 32109825Grape S, Jaunin E, El-Boghdadly K, Chan V, Albrecht E. Analgesic efficacy of PECS and serratus plane blocks after breast surgery: A systematic review, meta-analysis and trial sequential analysis. J Clin Anesth. 2020 Aug;63:109744. doi: 10.1016/j.jclinane.2020.109744. Epub 2020 Feb 25.
- Derived from this study: PubMed 40721998Ozguner Y, Yazar CO, Aydin F, Zengin M, Arik E, Kotanoglu MS, Altinsoy S, Ergil J. Comparison of the analgesic efficacy of combined superficial and deep serratus anterior plane block versus pectoserratus plane block following modified radical mastectomy surgery. BMC Anesthesiol. 2025 Jul 28;25(1):358. doi: 10.1186/s12871-025-03213-9.
- 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.
Yusuf Ozguner principal investigator
Ankara Etlik City 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 Pain, Postoperative, run by Ankara Etlik City 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 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 11 Apr 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?
Pain on the Numeric Rating Scale (NRS) (time frame: 0 hours postoperatively). The study lists 7 primary outcomes in all. 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 NCT05961735, which also lists 4 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 11 Apr 2025.