Analgesia Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | January 1, 2019 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of Sao Paulo | São Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Score | Patients will be actively questioned about their pain score assessment | 24 hours after surgery | |
Secondary | 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 |
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