Evaluation of Pectoral Nerve Blocks II for Augmentation Mammoplasty Surgeries. Prospective, Randomized, Double-blind Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pain Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
Normal Saline
General Anesthesia + Bilateral Pectoral injection of Normal Saline 0,9%
- Ultrasound-guided visualization of Pectoralis major and pectoralis minor muscles
- Injection of 10 mL normal saline 0,9% between muscles lateral to the thoracoacromial artery.
- 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
Intervention: Normal Saline 0,9% (Drug)
Bupivacaine
General Anesthesia + Bilateral Pectoral injection of 30 mL of 0.25% Bupivacaine
- Ultrasound-guided visualization of Pectoralis major and pectoralis minor muscles
- Injection of 10 mL of local anesthetic between muscles lateral to the thoracoacromial artery.
- 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
Intervention: Bupivacaine (Drug)
Outcomes
Primary Outcomes
Pain Score
Time Frame: 24 hours after surgery
Patients will be actively questioned about their pain score assessment
Secondary Outcomes
- Opioid Consumption(1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after surgery)
Investigators
Leonardo Henrique Cunha Ferraro
Professor
Federal University of São Paulo