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

Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery:a Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer; Anesthesia, Local
• Intervention / Treatment: Procedure: ESP BLOCK; Procedure: PECS BLOCK

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Veneto
    • Padova, Veneto, Italy, 35127
      • University of Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Mastectomy program with axillary clearence

Exclusion Criteria:

• bilateral surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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)	Procedure: ESP BLOCK; local anesthetic will be injected between transverous process and erector spinae muscle
ACTIVE_COMPARATOR: PECS block; Intervention:30 ml of 0.25% Levobupivacaine where:PECS II block as described by Blanco.	Procedure: PECS BLOCK; local anesthetic will be injected between pectoralis minor and pectoralis major (10 ml) and between pectoralis minor and serratus (20 ml); Other Names: 30 ml 0.25% Levobupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Fentanyl consumption	Intraoperative fentanyl dose (mcg) difference between ESP group and PECS group.	Intraoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Padova
• Investigators: Principal Investigator: Alessandro De Cassai, MD, Department of Medicine, DIMED - Section of Anesthesiology and Intensive Care. University of Padova

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2022
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (ACTUAL): January 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: RCT; PECS; ESP
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Levobupivacaine
• Other Study ID Numbers: ESPvsPECS/AOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Probably data will be shared at the end of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No