Pectoralis and Serratus Nerve Blocks for Mastectomy: a Prospective, Randomized, Single-blind Trial
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
sevoflurane and fentanil
sevoflurane and fentanil plus PECS II block
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Mastectomy, (PECs) pectoral block
Eligibility Criteria
Inclusion Criteria:
- Female patients, aged 18 to 60 years, electively scheduled to perform mastectomy in the Base Hospital of the Federal District;
- Physical State 1, 2 or 3 the American Society of Anesthesiology (ASA);
Exclusion Criteria:
- Patients with unstable angina
- Patient with poorly controlled asthma
- Substance abuse
- Heart failure, greater than first degree atrioventricular block
- Pregnant women
- Patients with allergy to dipyrone, morphine;
- Patients with chronic pain;
- Patients with severe hepatic disease;
- Patients with severe kidney disease;
- Patients with neurological diseases;
- Included patients in other clinical studies currently or in the past three months under general anesthesia;
- Patients who refuse to participate in the study;
- Any other condition that, in the opinion of the investigator, may pose a risk to the patient or interfere with the study objectives;
Sites / Locations
- Hospital de Base do Distrito FederalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo group
PECS II group
Arm Description
Patients in placebo group will receive general balanced inhaled anesthesia with sevoflurane and fentanil
Patients in PECS II group will receive general balanced inhaled anesthesia with sevoflurane and fentanil
Outcomes
Primary Outcome Measures
Pain Scores on the Visual Analogue Scale
Quantify pain by Visual Analogue Scale (VAS, ranging from 0 to 10 cm, zero being found when the patient is no pain and ten, with maximum or un bearable pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03966326
Brief Title
Pectoralis and Serratus Nerve Blocks for Mastectomy: a Prospective, Randomized, Single-blind Trial
Official Title
Pectoralis and Serratus Nerve Blocks for Mastectomy: a Prospective, Randomized, Single-blind, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Base
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pectoral nerve block provides a good alternative to epidural or paravertebral block with a lower risk for the patient and that is shown as an optimal anesthetic option with reduction in postoperative pain, anesthetic and opioid consumption. The main objective of this study is to evaluate the quality of the perioperative analgesia of the PECS block in patients electively escalated for the accomplishment of mastectomy under general anesthesia.
Detailed Description
The advent of ultrasound made possible greater safety and the creation of new peripheral blocks that aim to reduce the morbidity of the anesthetic technique on the cancer patient. Pectoral nerve block (PEC Block) is technically simple and easily reproducible. Inspired by the infraclavicular approach, it aims at the anesthesia of the pectoral, intercostobrachial, intercostal III-IV-V-VI nerves and the long thoracic nerve 8 being a safe, reproducible technique with little discomfort for the patients, with few complications and allowing a good control of acute pain.
The hypothesis is that the realization of pectoral nerve block provides a good alternative to epidural or paravertebral block with a lower risk for the patient and that is shown as an optimal anesthetic option with reduction in postoperative pain, anesthetic and opioid consumption. Main objective is the evaluation of postoperative pain through opioid consumption in the first 24 hours postoperatively.
Patients will undergo a prospective, randomized, single blind, placebo controlled study in which the examiners responsible for the postoperative evaluation will not know which of the two groups were randomly assigned: 40 patients in the Control and 40 patients in the PECS Group . Patients will be randomized through a list generated by www.randomizer.org into two groups.
Patients will receive standard monitoring, pre-anesthetic medication with midazolam 0.05 mg / kg EV. All patients will receive balanced general anesthesia with fentanyl 2 mcg / kg, lidocaine 2 mg / kg, propofol 1-2 mg / kg, cisatracurium 0.15 mg / kg or Rocuronium 0.6 mg / kg. The PECS II group will receive an injection of 20mL of 0.5% Ropivacaine between the serratus and the smaller pectoralis and 10mL of 0.5% ropivacaine between the pectoralis major and minor muscles with the aid of ultrasonography. Maintenance of anesthesia in the two groups: general anesthesia balanced with sevoflurane (with and fraction expired from 1 to 3%, to maintain BIS between 40 and 60). Prophylaxis for postoperative nausea and vomiting will be performed with slow intravenous administration following the anesthetic induction of Dexamethasone 4 mg, and at the end of the surgery slow intravenous administration of Ondansetron 4 mg. At the end of surgery, patients in both groups will receive Dipyrone 2 g and Parecoxib 40 mg. Patients will be evaluated in the postoperative times: T1: arrival at the PACU, T2: 3 hours postoperatively or discharge from the PACU), T3: 12 hours postoperative, T4: 24 hours postoperative.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Mastectomy, (PECs) pectoral block
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients in placebo group will receive general balanced inhaled anesthesia with sevoflurane and fentanil
Arm Title
PECS II group
Arm Type
Active Comparator
Arm Description
Patients in PECS II group will receive general balanced inhaled anesthesia with sevoflurane and fentanil
Intervention Type
Drug
Intervention Name(s)
sevoflurane and fentanil
Other Intervention Name(s)
Standard general anesthesia
Intervention Description
Patients will receive standard general anesthesia
Intervention Type
Drug
Intervention Name(s)
sevoflurane and fentanil plus PECS II block
Other Intervention Name(s)
Standard general anesthesia plus PECS II block
Intervention Description
Pacients will receive standard general anesthesia with sevoflurane and fentanil associated to PECS II block
Primary Outcome Measure Information:
Title
Pain Scores on the Visual Analogue Scale
Description
Quantify pain by Visual Analogue Scale (VAS, ranging from 0 to 10 cm, zero being found when the patient is no pain and ten, with maximum or un bearable pain
Time Frame
Within the first 24 hours after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients, aged 18 to 60 years, electively scheduled to perform mastectomy in the Base Hospital of the Federal District;
Physical State 1, 2 or 3 the American Society of Anesthesiology (ASA);
Exclusion Criteria:
Patients with unstable angina
Patient with poorly controlled asthma
Substance abuse
Heart failure, greater than first degree atrioventricular block
Pregnant women
Patients with allergy to dipyrone, morphine;
Patients with chronic pain;
Patients with severe hepatic disease;
Patients with severe kidney disease;
Patients with neurological diseases;
Included patients in other clinical studies currently or in the past three months under general anesthesia;
Patients who refuse to participate in the study;
Any other condition that, in the opinion of the investigator, may pose a risk to the patient or interfere with the study objectives;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabricio T Mendonça, MD
Phone
+5561981882640
Email
correidofabricio@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabricio T Mendonça, MD
Organizational Affiliation
Hospital de Base do Distrito Federal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Base do Distrito Federal
City
Brasilia
State/Province
DF
ZIP/Postal Code
70680250
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamil Elias, MD
Phone
556133151588
Email
uamphbdf@gmail.com
First Name & Middle Initial & Last Name & Degree
Viviane Rezende, MD
Phone
556133151331
Email
vrezende@icab.med.br
12. IPD Sharing Statement
Citations:
PubMed Identifier
29576125
Citation
O'Scanaill P, Keane S, Wall V, Flood G, Buggy DJ. Single-shot pectoral plane (PECs I and PECs II) blocks versus continuous local anaesthetic infusion analgesia or both after non-ambulatory breast-cancer surgery: a prospective, randomised, double-blind trial. Br J Anaesth. 2018 Apr;120(4):846-853. doi: 10.1016/j.bja.2017.11.112. Epub 2018 Feb 14.
Results Reference
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Pectoralis and Serratus Nerve Blocks for Mastectomy: a Prospective, Randomized, Single-blind Trial
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