PEC Block II in Mammoplasty Surgeries

Not Applicable

• Conditions: Mammaplasty; Anesthesia, Conduction; Analgesia; Analgesia, Patient-Controlled
• Interventions: Drug: Normal Saline 0,9%; Drug: Bupivacaine

• Registration Number: NCT03488888
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-14
• Study Start: 2017-11-03
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-03
• Last Update Submitted: 2018-04-03
• Study First Posted: 2018-04-05
• Last Update Posted: 2018-04-05
• Primary Completion: 2018-12-01
• Study Completion: 2019-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Female
• Above 18 years old
• Elective Surgery
• American Society of Anesthesia(ASA) Class I up to III

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline 0,9%	General Anesthesia + Bilateral Pectoral injection of Normal Saline 0,9% 1. Ultrasound-guided visualization of Pectoralis major and pectoralis minor muscles 2. Injection of 10 mL normal saline 0,9% between muscles lateral to the thoracoacromial artery. 3. 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
Bupivacaine	Bupivacaine	General Anesthesia + Bilateral Pectoral injection of 30 mL of 0.25% Bupivacaine 1. Ultrasound-guided visualization of Pectoralis major and pectoralis minor muscles 2. Injection of 10 mL of local anesthetic between muscles lateral to the thoracoacromial artery. 3. 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

Primary Outcome Measures

Name	Time	Method
Pain Score	24 hours after surgery	Patients will be actively questioned about their pain score assessment

Secondary Outcome Measures

Name	Time	Method
Opioid Consumption	1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after surgery	The total amount of opioid will be evaluated using an Patient Controlled Analgesia Pump

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 São Paulo, Sao Paulo, Brazil