Clinical trial NCT05427292: Combination of Serratus Anterior and Pectoral Nerve Blocks (PECS II) as Main Anesthetic Method in Breast Cancer Surgery
Official title: Feasibilty of Serratus Anterior and Pectoral Nerve Blocks (PECS II) Combination as Main Anesthetic Method in Breast Cancer Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: regional anesthesia
interfascial plane block
Main anesthetic method
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients aged 18-80 years with breast cancer

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sufficient surgical anesthesia
timeFrame: up to 30 minutes
Secondary outcomes:
measure: Pain scores on the Numeric Rating Scale (NRS)
timeFrame: up to 24 hours
measure: Quality of recovery 15 scale
timeFrame: up to 24 hours
measure: analgesic consumption
timeFrame: up to 24 hours
measure: modified Wilson Sedation Scale
timeFrame: up to 2 hours
measure: quality of anesthesia
timeFrame: up to 2 hours
measure: scaling working conditions
timeFrame: up to 2 hours
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University
state: Ilkadım
city: Samsun
country: Turkey
facility: Samsun University
Study officials:
affiliation: Samsun University
name: gamze MD ertaş, specialist
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.