PEC Block II in Mammoplasty Surgeries

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

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.

Study Overview

• Status: Unknown
• Conditions: Analgesia; Mammaplasty; Analgesia, Patient-Controlled; Anesthesia, Conduction
• Intervention / Treatment: Drug: Normal Saline 0,9%; Drug: Bupivacaine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paulo Cesar Castello Branco, MD; Phone Number: +55 (11) 5571-2746; Email: pccastellobranco@yahoo.com.br

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 04024002
      • Recruiting
      • Federal University of São Paulo
      • Contact: Paulo Cesar Castello Branco, MD; Phone Number: +55 (11) 5571-2746; Email: pccastellobranco@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Normal Saline; 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%; Ultrasound-guided PEC II block with 30 mL of Normal Saline 0,9%
Experimental: Bupivacaine; 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; Ultrasound-Guided PEC block with 30 mL of 0.25% bupivacaine solution; Other Names: Brand: Cristália

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Paulo Cesar Castello Branco, MD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: PEC Block

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No