Analgesia, Analgesia, Patient-Controlled, Anesthesia, Conduction, Mammaplasty
Conditions
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.
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.
Interventions
DRUGNormal Saline 0,9%
Ultrasound-guided PEC II block with 30 mL of Normal Saline 0,9%
DRUGBupivacaine
Ultrasound-Guided PEC block with 30 mL of 0.25% bupivacaine solution
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 24 hours after surgery | Patients will be actively questioned about their pain score assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Contacts
Primary ContactPaulo Cesar Castello Branco, MD
Outcome results
None listed