Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery
NCT ID: NCT03811262
Last Updated: 2022-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-01-01
2023-01-31
Brief Summary
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PECS II block is an interfascial block that has been used widely as regional anesthesia technique in breast surgery.
ESP block is a novel interfascial block proposed in 2016 by Forero. Several reports used this technique in breast surgery to provide analgesia but to date no studies comparing these technique exists.
Our hypotesis is that this two technique are equally able to provide analgesia in breast surgery.
Study type: RCT, single blind.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Patients will be randomly allocated to group "PECS" or "ESP" using a closed envelope technique.
Group "PECS" will receive PECS II block as described by Blanco using 30 ml Levobupivacaine 0.25% Group "ESP" will receive ESP block as described by forero using 30 ml Levobupivacaine 0.25% at T5 level.
Blocks will be executed after general anesthesia induction. All partecipants will receive Fentanyl 2 mcg/kg and Propofol 2 mg/kg for induction. Anesthesia will be mantained with Propofol to obtain a BIS level between 40-50. Patients will receive Fentanyl 33 mcg whenever blood pressure and/or hear rate raise more than 20% from baseline after surgical stimulation. At the end of the surgery patients will receive acetominophen 1 g. postoperative therapy: acetominophen 1g/8hr and ketoprofen 100 mg/12hr.
Patients will receive 2 mg Morphine whenever a NRS \> 3.
TREATMENT
TRIPLE
Anesthesiologist responsible for the surgery will be not aware of the block executed on the patient Anesthesiologist and surgeon responsible for postoperative therapy will be not aware of the block executed on the patient
Study Groups
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ESP BLOCK
Intervention:30 ml of 0.25% Levobupivacaine where: ESP block as described by Forero at T5 level (single injection between transversour process and erector spinae muscles)
ESP BLOCK
local anesthetic will be injected between transverous process and erector spinae muscle
PECS block
Intervention:30 ml of 0.25% Levobupivacaine where:PECS II block as described by Blanco.
PECS BLOCK
local anesthetic will be injected between pectoralis minor and pectoralis major (10 ml) and between pectoralis minor and serratus (20 ml)
Interventions
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ESP BLOCK
local anesthetic will be injected between transverous process and erector spinae muscle
PECS BLOCK
local anesthetic will be injected between pectoralis minor and pectoralis major (10 ml) and between pectoralis minor and serratus (20 ml)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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University of Padova
OTHER
Responsible Party
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Alessandro De Cassai
Principal Investigator
Principal Investigators
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Alessandro De Cassai, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine, DIMED - Section of Anesthesiology and Intensive Care. University of Padova
Locations
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University of Padova
Padua, Veneto, Italy
Countries
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Other Identifiers
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ESPvsPECS/AOP
Identifier Type: -
Identifier Source: org_study_id
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