NCT03488888

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

November 3, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

1.1 years

First QC Date

July 14, 2017

Last Update Submit

April 3, 2018

Conditions

MammaplastyAnesthesia, ConductionAnalgesiaAnalgesia, Patient-Controlled

Outcome Measures

Primary Outcomes (1)

  • Pain Score

    Patients will be actively questioned about their pain score assessment

    24 hours after surgery

Secondary Outcomes (1)

  • Opioid Consumption

    1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after surgery

Study Arms (2)

Normal Saline

SHAM COMPARATOR

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

Drug: Normal Saline 0,9%

Bupivacaine

EXPERIMENTAL

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

Drug: Bupivacaine

Interventions

Normal Saline 0,9%DRUG

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

Normal Saline
BupivacaineDRUG

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

Also known as: Brand: Cristália
Bupivacaine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04024002, Brazil

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Paulo Cesar Castello Branco, MD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulo Cesar Castello Branco, MD

CONTACT

+55 (11) 5571-2746pccastellobranco@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2017

First Posted

April 5, 2018

Study Start

November 3, 2017

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

April 5, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)