MammaplastyNCT03488888
PEC Block II in Mammoplasty Surgeries
A study testing Normal Saline 0,9% and Bupivacaine in people with Mammaplasty and Anesthesia, Conduction, run by Federal University of São Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammaplasty, Anesthesia, Conduction, Analgesia
- What is being tested?
- Normal Saline 0,9% and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Nov 2017to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Above 18 years old
- Elective Surgery
- American Society of Anesthesia(ASA) Class I up to III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Sao Paulo
São Paulo, São Paulo, 04024002
Paulo Cesar Castello Branco, MD, +55 (11) 5571-2746, pccastellobranco@yahoo.com.br
About this study
Official title: Evaluation of Pectoral Nerve Blocks II for Augmentation Mammoplasty Surgeries. Prospective, Randomized, Double-blind Study
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.
Read more
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.
Read the 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.
- Being tested
- Normal Saline 0,9%, Bupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline 0,9%Drug
Ultrasound-guided PEC II block with 30 mL of Normal Saline 0,9%
BupivacaineDrug
Also called Brand: Cristália
Ultrasound-Guided PEC block with 30 mL of 0.25% bupivacaine solution
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Sham comparator | General Anesthesia + Bilateral Pectoral injection of Normal Saline 0,9%
1. Ultrasound-guided visualization of Pectoralis major and pectoralis minor muscles
2. Injection of 10 mL normal saline 0,9% between muscles lateral to the thoracoacromial artery.
3. 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 Receives: Drug: Normal Saline 0,9% |
| Bupivacaine | Experimental | General Anesthesia + Bilateral Pectoral injection of 30 mL of 0.25% Bupivacaine
1. Ultrasound-guided visualization of Pectoralis major and pectoralis minor muscles
2. Injection of 10 mL of local anesthetic between muscles lateral to the thoracoacromial artery.
3. 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 Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Patients will be actively questioned about their pain score assessment
Measured: 24 hours after surgery
Secondary outcomes (1)
Opioid Consumption
The total amount of opioid will be evaluated using an Patient Controlled Analgesia Pump
Measured: 1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start3 Nov 2017
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammaplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Henrique Cunha Ferraro, Federal University of São Paulo
- Investigators
- Paulo Cesar Castello Branco, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488888
- Sponsor's protocol ID
- PEC Block
- Status last verified
- Apr 2018
- First submitted
- 14 Jul 2017
- Last updated
- 5 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pectoral Nerve Blocks II for Augmentation Mammoplasty Surgeries. Prospective, Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT03488888
- Acronym / sponsor ID
- PEC Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Sham comparator | Drug: Normal Saline 0,9%General Anesthesia + Bilateral Pectoral injection of Normal Saline 0,9% 1. Ultrasound-guided visualization of Pectoralis major and pectoralis minor muscles 2. Injection of 10 mL normal saline 0,9% between muscles lateral to the thoracoacromial artery. 3. 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 |
| Bupivacaine | Experimental | Drug: BupivacaineGeneral Anesthesia + Bilateral Pectoral injection of 30 mL of 0.25% Bupivacaine 1. Ultrasound-guided visualization of Pectoralis major and pectoralis minor muscles 2. Injection of 10 mL of local anesthetic between muscles lateral to the thoracoacromial artery. 3. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Above 18 years old
- Elective Surgery
- American Society of Anesthesia(ASA) Class I up to III
Key exclusion criteria (7 listed)
- Pregnancy
- Acute Coronary Syndrome
- History of Arrhythmia
- Functional Class New York Heart Association(NYHA) III or IV
- Previous thoracic/breast surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Saline 0,9%Ultrasound-guided PEC II block with 30 mL of Normal Saline 0,9% | Drug | Normal Saline |
| BupivacaineAlso: Brand: CristáliaUltrasound-Guided PEC block with 30 mL of 0.25% bupivacaine solution | Drug | Bupivacaine |
Primary outcome
Pain Score
Time frame: 24 hours after surgery
Patients will be actively questioned about their pain score assessment
1 secondary outcome
Opioid Consumption
Time frame: 1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulo Cesar Castello Branco, MD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Saline 0,9% and Bupivacaine in people with Mammaplasty and Anesthesia, Conduction, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paulo Cesar Castello Branco, MD (+55 (11) 5571-2746, pccastellobranco@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.