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Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery

Primary Purpose

Breast Cancer, Anesthesia, Local

Status
Withdrawn
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ESP BLOCK
PECS BLOCK
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring PECS, ESP, RCT

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mastectomy program with axillary clearence

Exclusion Criteria:

  • bilateral surgery

Sites / Locations

  • University of Padova

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ESP BLOCK

PECS block

Arm Description

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)

Intervention:30 ml of 0.25% Levobupivacaine where:PECS II block as described by Blanco.

Outcomes

Primary Outcome Measures

Intraoperative Fentanyl consumption
Intraoperative fentanyl dose (mcg) difference between ESP group and PECS group.

Secondary Outcome Measures

NRS at 6 hour
NRS (0-10) difference at sixth postoperative hour between ESP group and PECS group
NRS at 12 hour
NRS (0-10) difference at twelth postoperative hour between ESP group and PECS group
NRS at 24 hour
NRS (0-10) difference at twentyfourth postoperative hour between ESP group and PECS group
Patient satisfaction at 24 hour
Patient satisfaction (0-10) difference regarding anesthesia management at twentyfourth postoperative hour between ESP group and PECS group
Time to first opioid consumption in the postoperative period
Time (minutes) to first opioid consumption in the postoperative period
Postoperative morphine consumption
postoperative morphine dose (mg) difference between ESP group and PECS group.
Nausea and vomit incidence
Incidence of nausea and vomiting in postoperative period
Other complication incidence
Incidence of other complcations linked to anesthesia in postoperative period
Intraoperative Fentanyl consumption(mcg/kg/h)
Intraoperative fentanyl dose (mcg/kg/h) difference between ESP group and PECS group.

Full Information

First Posted
January 17, 2019
Last Updated
May 16, 2022
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT03811262
Brief Title
Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery
Official Title
Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery:a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Logistic reasons (Operating room performing the surgery investigated moved to another structure)
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Backgroung:Regional anesthesia in breast surgery is of paramount importance to reduce pain in perioperative period. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Anesthesia, Local
Keywords
PECS, ESP, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a single-centre, prospective; double blinded randomised interventional clinical trial. 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.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
ESP block and PECS block will be executed by an anesthesiologist that will not follow the patient during the surgery. 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
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESP BLOCK
Arm Type
Active Comparator
Arm Description
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)
Arm Title
PECS block
Arm Type
Active Comparator
Arm Description
Intervention:30 ml of 0.25% Levobupivacaine where:PECS II block as described by Blanco.
Intervention Type
Procedure
Intervention Name(s)
ESP BLOCK
Intervention Description
local anesthetic will be injected between transverous process and erector spinae muscle
Intervention Type
Procedure
Intervention Name(s)
PECS BLOCK
Other Intervention Name(s)
30 ml 0.25% Levobupivacaine
Intervention Description
local anesthetic will be injected between pectoralis minor and pectoralis major (10 ml) and between pectoralis minor and serratus (20 ml)
Primary Outcome Measure Information:
Title
Intraoperative Fentanyl consumption
Description
Intraoperative fentanyl dose (mcg) difference between ESP group and PECS group.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
NRS at 6 hour
Description
NRS (0-10) difference at sixth postoperative hour between ESP group and PECS group
Time Frame
sixth postoperative hour
Title
NRS at 12 hour
Description
NRS (0-10) difference at twelth postoperative hour between ESP group and PECS group
Time Frame
twelth postoperative hour
Title
NRS at 24 hour
Description
NRS (0-10) difference at twentyfourth postoperative hour between ESP group and PECS group
Time Frame
twentyfourth postoperative hour
Title
Patient satisfaction at 24 hour
Description
Patient satisfaction (0-10) difference regarding anesthesia management at twentyfourth postoperative hour between ESP group and PECS group
Time Frame
postoperative period (24h)
Title
Time to first opioid consumption in the postoperative period
Description
Time (minutes) to first opioid consumption in the postoperative period
Time Frame
postoperative period (24h)
Title
Postoperative morphine consumption
Description
postoperative morphine dose (mg) difference between ESP group and PECS group.
Time Frame
postoperative period (24h)
Title
Nausea and vomit incidence
Description
Incidence of nausea and vomiting in postoperative period
Time Frame
postoperative period (24h)
Title
Other complication incidence
Description
Incidence of other complcations linked to anesthesia in postoperative period
Time Frame
postoperative period (24h)
Title
Intraoperative Fentanyl consumption(mcg/kg/h)
Description
Intraoperative fentanyl dose (mcg/kg/h) difference between ESP group and PECS group.
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mastectomy program with axillary clearence Exclusion Criteria: bilateral surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro De Cassai, MD
Organizational Affiliation
Department of Medicine, DIMED - Section of Anesthesiology and Intensive Care. University of Padova
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35127
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Probably data will be shared at the end of the study

Learn more about this trial

Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery

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