search
Back to results

PEC Block II in Mammoplasty Surgeries

Primary Purpose

Mammaplasty, Anesthesia, Conduction, Analgesia

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Normal Saline 0,9%
Bupivacaine
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mammaplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Federal University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Normal Saline

Bupivacaine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain Score
Patients will be actively questioned about their pain score assessment

Secondary Outcome Measures

Opioid Consumption
The total amount of opioid will be evaluated using an Patient Controlled Analgesia Pump

Full Information

First Posted
July 14, 2017
Last Updated
April 3, 2018
Sponsor
Federal University of São Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT03488888
Brief Title
PEC Block II in Mammoplasty Surgeries
Official Title
Evaluation of Pectoral Nerve Blocks II for Augmentation Mammoplasty Surgeries. Prospective, Randomized, Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 3, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
January 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mammaplasty, Anesthesia, Conduction, Analgesia, Analgesia, Patient-Controlled

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal Saline
Arm Type
Sham Comparator
Arm Description
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
Arm Title
Bupivacaine
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Normal Saline 0,9%
Intervention Description
Ultrasound-guided PEC II block with 30 mL of Normal Saline 0,9%
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Brand: Cristália
Intervention Description
Ultrasound-Guided PEC block with 30 mL of 0.25% bupivacaine solution
Primary Outcome Measure Information:
Title
Pain Score
Description
Patients will be actively questioned about their pain score assessment
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Opioid Consumption
Description
The total amount of opioid will be evaluated using an Patient Controlled Analgesia Pump
Time Frame
1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paulo Cesar Castello Branco, MD
Phone
+55 (11) 5571-2746
Email
pccastellobranco@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo Cesar Castello Branco, MD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Sao Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04024002
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulo Cesar Castello Branco, MD
Phone
+55 (11) 5571-2746
Email
pccastellobranco@yahoo.com.br

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PEC Block II in Mammoplasty Surgeries

We'll reach out to this number within 24 hrs