Clincosm LogoSign in Get a demo

PEC Block II in Mammoplasty Surgeries

Sponsor
Federal University of São Paulo (Other)
Overall Status
Unknown status
CT.gov ID
NCT03488888
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
13.9
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluation of Pectoral Nerve Blocks II for Augmentation Mammoplasty Surgeries. Prospective, Randomized, Double-blind Study
Actual Study Start Date :
Nov 3, 2017
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Jan 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain Score [24 hours after surgery]

      Patients will be actively questioned about their pain score assessment

    Secondary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Federal University of Sao Paulo São Paulo Sao Paulo Brazil 04024002

    Sponsors and Collaborators

    • Federal University of São Paulo

    Investigators

    • Principal Investigator: Paulo Cesar Castello Branco, MD, Federal University of Sao Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Leonardo Henrique Cunha Ferraro, Professor, Federal University of São Paulo
    ClinicalTrials.gov Identifier:
    NCT03488888
    Other Study ID Numbers:
    • PEC Block
    First Posted:
    Apr 5, 2018
    Last Update Posted:
    Apr 5, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Agnosia
    Bupivacaine

    Study Results

    No Results Posted as of Apr 5, 2018