Clinical trial NCT03488888: PEC Block II in Mammoplasty Surgeries
Official title: Evaluation of Pectoral Nerve Blocks II for Augmentation Mammoplasty Surgeries. Prospective, Randomized, Double-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mammaplasty
Anesthesia, Conduction
Analgesia
Analgesia, Patient-Controlled
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Score
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Opioid Consumption
timeFrame: 1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after surgery
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Paulo Cesar Castello Branco, MD
role: PRINCIPAL_INVESTIGATOR
References: