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

NCT03811262 | Withdrawn

• 1 other identifier: ESPvsPECS/AOP
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Anesthesia, Local

Keywords

PECS; ESP; RCT

Outcome Measures

Primary Outcomes (1)

• Intraoperative Fentanyl consumption

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

  Intraoperative

Secondary Outcomes (9)

• NRS at 6 hour

  sixth postoperative hour

• NRS at 12 hour

  twelth postoperative hour

• NRS at 24 hour

  twentyfourth postoperative hour

• Patient satisfaction at 24 hour

  postoperative period (24h)

• Time to first opioid consumption in the postoperative period

  postoperative period (24h)

Study Arms (2)

ESP BLOCK

ACTIVE COMPARATOR

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

PECS block

ACTIVE COMPARATOR

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

Procedure: PECS BLOCK

Interventions

ESP BLOCK PROCEDURE

local anesthetic will be injected between transverous process and erector spinae muscle

ESP BLOCK

PECS BLOCK PROCEDURE

local anesthetic will be injected between pectoralis minor and pectoralis major (10 ml) and between pectoralis minor and serratus (20 ml)

Also known as: 30 ml 0.25% Levobupivacaine

PECS block

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mastectomy program with axillary clearence

You may not qualify if:

• bilateral surgery

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University of Padova

Padua, Veneto, 35127, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Alessandro De Cassai, MD

  Department of Medicine, DIMED - Section of Anesthesiology and Intensive Care. University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 22, 2019
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

IT (1)