Combination of Serratus Anterior and Pectoral Nerve Blocks (PECS II) as Main Anesthetic Method in Breast Cancer Surgery

NCT05427292 | Completed

• 1 other identifier: SamsunU
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Anesthesia

Keywords

regional anesthesia; interfascial plane block; Main anesthetic method

Outcome Measures

Primary Outcomes (1)

• 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'.

  up to 30 minutes

Secondary Outcomes (6)

• Pain scores on the Numeric Rating Scale (NRS)

  up to 24 hours

• Quality of recovery 15 scale

  up to 24 hours

• analgesic consumption

  up to 24 hours

• modified Wilson Sedation Scale

  up to 2 hours

• quality of anesthesia

  up to 2 hours

Interventions

serratus anterior block and PECs II block combination OTHER

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients aged 18-80 years with breast cancer

You may qualify if:

• Patients between the ages of 18-80 and ASA I-III who will undergo unilateral breast cancer surgery will be included in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsun University: lead

Study Sites (2)

Samsun University

Samsun, Ilkadım, 55100, Turkey (Türkiye)

Location

Samsun University

Samsun, 55040, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 29327341 RESULT

• 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.

  PMID: 22939099 RESULT

Study Officials

• gamze MD ertaş, specialist

  Samsun University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 22, 2022
• Study Start: July 7, 2022
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: July 10, 2023

Record last verified: 2023-07

Locations

TU (2)