AnesthesiaNCT05427292
Combination of Serratus Anterior and Pectoral Nerve Blocks (PECS II) as Main Anesthetic Method in Breast Cancer Surgery
An observational study of Anesthesia, run by Samsun University at 2 sites in Turkey (Türkiye).
Trial summary
Aim of this study is to determine the success of combined serratus anterior and PECS-2 block as the main anesthetic method in breast cancer surgery and also to investigate the patient acceptability of this combination and its relationship with surgeon satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- serratus anterior block and PECs II block combination
- How many people
- 17 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 7 Jul 2022to 7 Jul 2023
- How long will I take part?
- 1 Year
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients aged 18-80 years with breast cancer
Who may be able to join
- Patients between the ages of 18-80 and ASA I-III who will undergo unilateral breast cancer surgery will be included in the study.
Who cannot join
- Patients with previous breast surgery other than excisional biopsy,
- coagulopathy,
- bleeding disease,
- local infection at the injection site,
- history of local anesthetic allergy,
- psychiatric disease (depression, mania, schizophrenia or antipsychotic drug use),
Show all 9Show fewer
- history of opioid use for more than 4 weeks
- Patients with body mass index (BMI) >40kg/m2 and
- chest deformity (pectus excavatum and pectus carinatum) will be excluded from the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Samsun University
Samsun, Ilkadım, 55100
Samsun University
Samsun, 55040
About this study
Official title: Feasibilty of Serratus Anterior and Pectoral Nerve Blocks (PECS II) Combination as Main Anesthetic Method in Breast Cancer Surgery Patients
Aim of this study is to determine the success of combined serratus anterior and PECS-2 block as the main anesthetic method in breast cancer surgery and also to investigate the patient acceptability of this combination and its relationship with surgeon satisfaction.
Read the detailed description
Breast conserving surgery or mastectomy is applied in the surgical treatment of breast cancer. Axillary interventions range from sentinal lymph node biopsy to lymph node dissection. Clinically significant acute pain develops following breast surgery in 35% of patients.
Today, regional anesthesia is widely used as an opioid-sparing strategy in the treatment of acute postoperative pain. New fascial plane blocks have been developed as alternative or complementary techniques for chest wall analgesia, including pectoral nerve blocks (PECS1-2) and serratus plane block.
In order to reduce the risk of perioperative morbidity and mortality and to meet the patient demand, the demand for awake surgery is increasing in institutions.
Therefore, a prospective observational case series was conducted to explain the efficacy, patient acceptability, and surgeon satisfaction of combined serratus anterior and PECS-2 block as the main anesthetic method for breast cancer surgery.
- Conditions
- Anesthesia
- Being tested
- serratus anterior block and PECs II block combination
- Keywords
- regional anesthesia, interfascial plane block, Main anesthetic method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serratus anterior block and PECs II block combinationOther
The pre-surgery block will be applied. Sensorial block will be evaluated at the surgical incision site with the pinpirick test at 30 minutes after the block, and if the block is successful, surgery will begin.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sufficient surgical anesthesia
After confirming the sensory block in the surgical area with the post-procedure pinpirick test, successful completion of the surgical procedure 'without the need for deep sedoanalgesia' will be considered 'sufficient surgical anesthesia'.
Measured: up to 30 minutes
Secondary outcomes (6)
Pain scores on the Numeric Rating Scale (NRS)
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: up to 24 hours
Quality of recovery 15 scale
Postoperative Quality of Recovery 15 in Turkish scale
Measured: up to 24 hours
analgesic consumption
In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected
Measured: up to 24 hours
modified Wilson Sedation Scale
- Oriente, eyes may be closed, but says his name, answers where he is
- Sleepy, eyes may be closed, can be warned when called by name
- Can be stimulated by mild physical stimulation (earlobe)
- Cannot be stimulated by mild physical stimulation
Measured: up to 2 hours
quality of anesthesia
Are you satisfied with the anesthesia? Would you like to have surgery with the same technique again? Would you recommend it to others?
- Extremely satisfied,
- Satisfied,
- Neither satisfied nor dissatisfied,
- Not satisfied,
- It will be calculated by responding as highly dissatisfied.
Measured: up to 2 hours
scaling working conditions
Working conditions scaling
Indistinguishable from general anesthesia A little challenging/enough It will be determined by choosing one of the overly challenging/inadequate options.
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start7 Jul 2022
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
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 AnesthesiaStudies 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
- 17 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Ertas, Samsun University
- Investigators
- gamze MD ertaş, specialist, Principal investigator, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427292
- Sponsor's protocol ID
- SamsunU
- Status last verified
- Jul 2023
- First submitted
- 13 Jun 2022
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pawa A, Wight J, Onwochei DN, Vargulescu R, Reed I, Chrisman L, Pushpanathan E, Kothari A, El-Boghdadly K. Combined thoracic paravertebral and pectoral nerve blocks for breast surgery under sedation: a prospective observational case series. Anaesthesia. 2018 Apr;73(4):438-443. doi: 10.1111/anae.14213. Epub 2018 Jan 12.
PubMed 29327341Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
PubMed 22939099
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibilty of Serratus Anterior and Pectoral Nerve Blocks (PECS II) Combination as Main Anesthetic Method in Breast Cancer Surgery Patients
- ClinicalTrials.gov ID
- NCT05427292
- Acronym / sponsor ID
- SamsunU
- Conditions
- Anesthesia
- Keywords
- regional anesthesia, interfascial plane block, Main anesthetic method
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 22 Jun 2022 (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.
Aim of this study is to determine the success of combined serratus anterior and PECS-2 block as the main anesthetic method in breast cancer surgery and also to investigate the patient acceptability of this combination and its relationship with surgeon satisfaction.
Detailed description
Breast conserving surgery or mastectomy is applied in the surgical treatment of breast cancer. Axillary interventions range from sentinal lymph node biopsy to lymph node dissection. Clinically significant acute pain develops following breast surgery in 35% of patients.
Today, regional anesthesia is widely used as an opioid-sparing strategy in the treatment of acute postoperative pain. New fascial plane blocks have been developed as alternative or complementary techniques for chest wall analgesia, including pectoral nerve blocks (PECS1-2) and serratus plane block.
In order to reduce the risk of perioperative morbidity and mortality and to meet the patient demand, the demand for awake surgery is increasing in institutions.
Therefore, a prospective observational case series was conducted to explain the efficacy, patient acceptability, and surgeon satisfaction of combined serratus anterior and PECS-2 block as the main anesthetic method for breast cancer surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged 18-80 years with breast cancer
Key inclusion criteria (1 listed)
- Patients between the ages of 18-80 and ASA I-III who will undergo unilateral breast cancer surgery will be included in the study.
Key exclusion criteria (9 listed)
- Patients with previous breast surgery other than excisional biopsy,
- coagulopathy,
- bleeding disease,
- local infection at the injection site,
- history of local anesthetic allergy,
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 |
|---|---|---|
| serratus anterior block and PECs II block combinationThe pre-surgery block will be applied. Sensorial block will be evaluated at the surgical incision site with the pinpirick test at 30 minutes after the block, and if the block is successful, surgery will begin. | Other | – |
Primary outcome
Sufficient surgical anesthesia
Time frame: up to 30 minutes
After confirming the sensory block in the surgical area with the post-procedure pinpirick test, successful completion of the surgical procedure 'without the need for deep sedoanalgesia' will be considered 'sufficient surgical anesthesia'.
6 secondary outcomes
Pain scores on the Numeric Rating Scale (NRS)
Time frame: up to 24 hours
Quality of recovery 15 scale
Time frame: up to 24 hours
analgesic consumption
Time frame: up to 24 hours
modified Wilson Sedation Scale
Time frame: up to 2 hours
quality of anesthesia
Time frame: up to 2 hours
scaling working conditions
Time frame: up to 2 hours
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 10 Jul 2023.
- Results publication: PubMed 29327341Pawa A, Wight J, Onwochei DN, Vargulescu R, Reed I, Chrisman L, Pushpanathan E, Kothari A, El-Boghdadly K. Combined thoracic paravertebral and pectoral nerve blocks for breast surgery under sedation: a prospective observational case series. Anaesthesia. 2018 Apr;73(4):438-443. doi: 10.1111/anae.14213. Epub 2018 Jan 12.
- Results publication: PubMed 22939099Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
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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.
gamze MD ertaş, specialist principal investigator
Samsun University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Samsun University at 2 sites 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 1 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 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Sufficient surgical anesthesia (time frame: up to 30 minutes). 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 NCT05427292, 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 10 Jul 2023.