PEC Block II in Mammoplasty Surgeries

Study Overview
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Brief Summary
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Breast augmentation surgery is the top cosmetic surgery in USA with more then 300.000 cases performed annually. Pain is a common complications of the procedure accompanied of dyspnea and nausea due to the surgical manipulation. Several anesthetic techniques were developed with the objective of providing optimal surgical conditions together with enhanced recovery and post-op pain management. Pectoralis major block was first described in 2011 by Blanco in female patients undergoing oncologic procedures in the anterior thoracic wall. The investigators hypothesized if the Pectoralis Major block combined with general anesthesia standard techniques could be beneficial in improving pain scores and opioid consumption during post operative period of patients undergoing breast augmentation surgery.

Detailed Description
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Patients undergoing Breast Augmentation Mammoplasty were submitted to laryngeal mask placement after anesthetic induction with Fentanyl 3ucg/kg , Propofol 2mg/kg and Atracurium 0,5mg/kg and surgery was performed under standard surgical practices. Before the surgical incision patients were randomized either to receive a Bilateral Pectoralis Major Block(PEC I and II) with Bupivacaine 0,25% with Epinephrine or to receive a placebo block with Normal Saline 0,9%. After the procedure all patients received a intravenous patient-controlled-analgesia pump device with morphine. Pain and opioid consumption were assessed with a pain score assessment tool and assessment of the pump administration dosage history. No NSAIDs or alpha 2 agonist drugs were administered during or after the procedure. The maintenance of anesthesia was performed with Propofol and Remifentanil Total intravenous anesthesia(TIVA) models in a standardized fashion. Micromanagement of anesthetic drugs was performed by the assistant anesthesiologist physician.

Official Title
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Evaluation of Pectoral Nerve Blocks II for Augmentation Mammoplasty Surgeries. Prospective, Randomized, Double-blind Study

Conditions
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Mammaplasty, Anesthesia, Conduction, Analgesia, Analgesia, Patient-Controlled

Intervention / Treatment
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* Drug: Normal Saline 0,9%
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Above 18 years old Elective Surgery American Society of Anesthesia(ASA) Class I up to III Exclusion Criteria: Pregnancy Acute Coronary Syndrome History of Arrhythmia Functional Class New York Heart Association(NYHA) III or IV Previous thoracic/breast surgery History of Chronic Pain Neuromuscular disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Normal Saline<br>General Anesthesia + Bilateral Pectoral injection of Normal Saline 0,9% Ultrasound-guided visualization of Pectoralis major and pectoralis minor muscles Injection of 10 mL normal saline 0,9% between muscles lateral to the thoracoacromial artery. Visualization of Pectoralis menor and Serratil Muscles 3- Injection of 20 mL of normal saline 0,9% between Pectoralis minor and serratil muscles 4-Visualize the hydrodissection performed by the solution | Drug: Normal Saline 0,9%<br>* Ultrasound-guided PEC II block with 30 mL of Normal Saline 0,9%<br>|
| Experimental: Bupivacaine<br>General Anesthesia + Bilateral Pectoral injection of 30 mL of 0.25% Bupivacaine Ultrasound-guided visualization of Pectoralis major and pectoralis minor muscles Injection of 10 mL of local anesthetic between muscles lateral to the thoracoacromial artery. Visualization of Pectoralis minor and Serratil Muscles 3- Injection of 20 mL of local anesthestic between Pectoralis minor and Serratil muscles 4-Visualize the hydrodissection performed by the solution | Drug: Bupivacaine<br>* Ultrasound-Guided PEC block with 30 mL of 0.25% bupivacaine solution<br>* Other names: Brand: Cristália;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Patients will be actively questioned about their pain score assessment | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | The total amount of opioid will be evaluated using an Patient Controlled Analgesia Pump | 1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after surgery |