PEC Block II in Mammoplasty Surgeries

NCT ID: NCT03488888

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-03
• Study Completion Date: 2019-01-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Normal Saline

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

Group Type: SHAM_COMPARATOR

Normal Saline 0,9%

Intervention Type: DRUG

Ultrasound-guided PEC II block with 30 mL of Normal Saline 0,9%

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

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

Ultrasound-Guided PEC block with 30 mL of 0.25% bupivacaine solution

Interventions

Normal Saline 0,9%

Ultrasound-guided PEC II block with 30 mL of Normal Saline 0,9%

Intervention Type: DRUG

Bupivacaine

Ultrasound-Guided PEC block with 30 mL of 0.25% bupivacaine solution

Intervention Type: DRUG

Other Intervention Names

Brand: Cristália

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Leonardo Henrique Cunha Ferraro

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paulo Cesar Castello Branco, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Paulo Cesar Castello Branco, MD

Role: CONTACT

pccastellobranco@yahoo.com.br

+55 (11) 5571-2746

Facility Contacts

Paulo Cesar Castello Branco, MD

Role: primary

pccastellobranco@yahoo.com.br

+55 (11) 5571-2746

Other Identifiers

PEC Block

Identifier Type: -

Identifier Source: org_study_id