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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline | Sham Comparator | General Anesthesia + Bilateral Pectoral injection of Normal Saline 0,9%
3- Injection of 20 mL of normal saline 0,9% between Pectoralis minor and serratil muscles 4-Visualize the hydrodissection performed by the solution |
|
| Bupivacaine | Experimental | General Anesthesia + Bilateral Pectoral injection of 30 mL of 0.25% Bupivacaine
3- Injection of 20 mL of local anesthestic between Pectoralis minor and Serratil muscles 4-Visualize the hydrodissection performed by the solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Saline 0,9% | Drug | Ultrasound-guided PEC II block with 30 mL of Normal Saline 0,9% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | Patients will be actively questioned about their pain score assessment | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paulo Cesar Castello Branco, MD | Contact | +55 (11) 5571-2746 | pccastellobranco@yahoo.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Paulo Cesar Castello Branco, MD | Federal University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Sao Paulo | Recruiting | São Paulo | São Paulo | 04024002 | Brazil |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine |
| Drug |
Ultrasound-Guided PEC block with 30 mL of 0.25% bupivacaine solution |
|
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |