PEC Block II in Mammoplasty Surgeries

Analgesia Clinical Trial

Official title:

Evaluation of Pectoral Nerve Blocks II for Augmentation Mammoplasty Surgeries. Prospective, Randomized, Double-blind Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03488888
• Other study ID #: PEC Block
• Status: Recruiting
• Phase: N/A
• First received: July 14, 2017
• Last updated: April 3, 2018
• Start date: November 3, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: April 2018
• Source: Federal University of São Paulo
• Contact: Paulo Cesar Castello Branco, MD
• Phone: +55 (11) 5571-2746
• Email: pccastellobranco[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Analgesia, Patient-Controlled
• Anesthesia, Conduction
• Mammaplasty

Intervention

Drug:
• Normal Saline 0,9%
Ultrasound-guided PEC II block with 30 mL of Normal Saline 0,9%
• Bupivacaine
Ultrasound-Guided PEC block with 30 mL of 0.25% bupivacaine solution

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	Patients will be actively questioned about their pain score assessment	24 hours after surgery
Secondary	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