Combination of Serratus Anterior and Pectoral Nerve Blocks (PECS II) as Main Anesthetic Method in Breast Cancer Surgery
Feasibilty of Serratus Anterior and Pectoral Nerve Blocks (PECS II) Combination as Main Anesthetic Method in Breast Cancer Surgery Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Samsun, Turkey, 55040
- Samsun University
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Ilkadım
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Samsun, Ilkadım, Turkey, 55100
- Samsun University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients between the ages of 18-80 and ASA I-III who will undergo unilateral breast cancer surgery will be included in the study.
Exclusion Criteria:
- 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),
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sufficient surgical anesthesia
Time Frame: up to 30 minutes
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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'.
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up to 30 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain scores on the Numeric Rating Scale (NRS)
Time Frame: up to 24 hours
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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").
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up to 24 hours
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Quality of recovery 15 scale
Time Frame: up to 24 hours
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Postoperative Quality of Recovery 15 in Turkish scale
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up to 24 hours
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analgesic consumption
Time Frame: up to 24 hours
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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
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up to 24 hours
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modified Wilson Sedation Scale
Time Frame: up to 2 hours
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up to 2 hours
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quality of anesthesia
Time Frame: up to 2 hours
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Are you satisfied with the anesthesia? Would you like to have surgery with the same technique again? Would you recommend it to others?
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up to 2 hours
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scaling working conditions
Time Frame: up to 2 hours
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Working conditions scaling Indistinguishable from general anesthesia A little challenging/enough It will be determined by choosing one of the overly challenging/inadequate options. |
up to 2 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: gamze MD ertaş, specialist, Samsun University
Publications and helpful links
General Publications
- Blanco 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SamsunU (Other Identifier: Samsun university)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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