Comparison of Erector Spinae Plane Block and Pectoral Nerve Block for Acute and Chronic Pain in Mastectomies

NCT05069805 | Unknown

• 1 other identifier: PECS vs ESP
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Ultrasound-guided blockage of the erector plane of the spine (known as ESP BLOCK) is a recently described block and a very useful strategy in the perioperative period as it provides effective analgesia in thoracic surgery. Ultrasound-guided type II pectoral nerve block (internationally known by the acronym Pecs II block) is a very useful strategy in the perioperative period because it provides effective analgesia in breast surgeries and can optimize results. The aim of this study is to assess perioperative pain in mastectomies. This is a prospective, randomized, single-blinded study that will compare the effects of spinal erector plane block versus pectoral nerve block in patients scheduled for mastectomy. The ESP group will receive balanced general anesthesia associated with ESP BLOCK with 0.5% ropivacaine guided by ultrasound. The Pecs II group will receive balanced general anesthesia associated with Pecs II block with 0.5% ropivacaine guided by USG.

Conditions

Acute Pain; Chronic Pain; Mastectomy

Keywords

Acute pain; Chronic pain; Mastectomy

Outcome Measures

Primary Outcomes (1)

• Analgesic consumption during surgery

  The amount of opioid analgesics consumed during surgery

  During the surgery

Secondary Outcomes (7)

• Anesthetics consumption during surgery

  During the surgery

• Tramadol consumption in post-operative

  Within the first 24 hours after surgery

• Pain Scores on the Numeric Rating Scale

  Within the first 24 hours after surgery

• Number of participants with adverse events as a measure of safety and tolerability

  During the surgery

• Number of participants with adverse events as a measure of safety and tolerability

  Within the first 24 hours after surgery

Study Arms (2)

PECS II block group

ACTIVE COMPARATOR

Patients in PECS II group will receive general balanced inhaled anesthesia with sevoflurane and fentanyl

Procedure: PECS II block; Procedure: ESP block

ESP block group

ACTIVE COMPARATOR

Patients in ESP group will receive general balanced inhaled anesthesia with sevoflurane and fentanyl

Procedure: PECS II block; Procedure: ESP block

Interventions

PECS II block PROCEDURE

Patients will receive standard general anesthesia with sevoflurane and fentanyl associated to PECS II block

ESP block group; PECS II block group

ESP block PROCEDURE

Patients will receive standard general anesthesia with sevoflurane and fentanyl associated to ESP block

ESP block group; PECS II block group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients, aged between 18 and 70 years, electively scheduled for mastectomy at Hospital Regional de Sobradinho and Hospital de Base do Distrito Federal;
• American Society of Anesthesiology (ASA) physical status I, II or III

You may not qualify if:

• Patient with severe heart disease;
• Patient with severe liver disease;
• Patient with severe kidney disease;
• Patient with a neurological disease;
• Use of psychoactive drugs;
• Pregnant women;
• Patients with allergies to any medication used in the study;
• Patients with chronic pain;
• Patients who refused to participate in the study.

Sponsors & Collaborators

• Hospital de Base: lead

Study Sites (1)

Hospital de Base do Distrito Federal

Brasília, Federal District, 70330150, Brazil

RECRUITING

Related Publications (1)

• Sinha C, Kumar A, Kumar A, Prasad C, Singh PK, Priya D. Pectoral nerve versus erector spinae block for breast surgeries: A randomised controlled trial. Indian J Anaesth. 2019 Aug;63(8):617-622. doi: 10.4103/ija.IJA_163_19.

  PMID: 31462806 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcus Alexandre Avis, MD

  Hospital de Base do Distrito Federal

  STUDY DIRECTOR

Central Study Contacts

Fabrício T Mendonça, MD, MSc

CONTACT

556133151588; correiodofabricio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researcher responsible for the postoperative period, the surgical team and the patients were not aware of the allocated groups. The researcher responsible for the randomization list communicated the researcher responsible for performing the ESP or PECS II block and conducting the anesthesia.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Residency Preceptor

Model Details: Prospective, randomized, single-blind, superiority study

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: October 6, 2021
• Study Start: October 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 5, 2021

Record last verified: 2021-10

Locations

BR (1)