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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05427292
• Other study ID #: SamsunU
• Status: Completed
• Start date: July 7, 2022
• Est. completion date: July 7, 2023

Study information

• Verified date: July 2023
• Source: Samsun University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 7, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Other:
• serratus anterior block and PECs II block combination
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.

Locations

Country	Name	City	State
Turkey	Samsun University	Samsun	Ilkadim
Turkey	Samsun University	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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").	up to 24 hours
Secondary	Quality of recovery 15 scale	Postoperative Quality of Recovery 15 in Turkish scale	up to 24 hours
Secondary	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	up to 24 hours
Secondary	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	up to 2 hours
Secondary	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.	up to 2 hours
Secondary	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.	up to 2 hours