An interventional study of Normal Saline 0,9% and Bupivacaine in Mammaplasty, Anesthesia, Conduction and Analgesia, sponsored by Federal University of São Paulo. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment
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.
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.
Federal University of São Paulo is the lead sponsor of 439 studies on the registry; 23 are open to participants now.
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NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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%
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
Ultrasound-guided PEC II block with 30 mL of Normal Saline 0,9%
Ultrasound-Guided PEC block with 30 mL of 0.25% bupivacaine solution
Also known as: Brand: Cristália
Pain Score
Patients will be actively questioned about their pain score assessment
Time frame: 24 hours after surgery
Opioid Consumption
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
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine
Agnosia
Federal University of São Paulo →