Combined PECS II and Transversus Plane Blocks Versus Erector Spinae Block in Modified Radical Mastectomy

NCT03903224 | Completed

• 1 other identifier: Analgesia in breast surgey
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the total morphine consumption in the first 24 hour postoperative between combined modified pectoralis block (PECS II) and transversus plane block versus erector spinae block in modified radical mastectomy.

Conditions

Breast Cancer; Acute Postoperative Pain

Keywords

Breast Cancer; Regional Anaesthesia; Morphine Consumption

Outcome Measures

Primary Outcomes (1)

• The total morphine consumption postoperative (mg)

  Morphine consumption in mg

  The first 24 hours postoperative.

Secondary Outcomes (4)

• Postoperative pain score by Verbal numeric rating scale

  0, 2, 4, 8, 12, 24 hours postoperatively.

• Time to first request analgesia postoperative (min)

  The first 24 hours postoperatively

• Postoperative level of IL6 (interleukin 6) (pg/mL)

  Two blood samples will be withdrawn from the patient. The first one is immediately preoperative and the second one after 24 hours postoperative

• Arterial blood gas: Arterial blood gas: Arterial blood gases

  Before surgery and 24 hours postoperative.

Study Arms (2)

Combined PECS II and TTP blocks (PT)

ACTIVE COMPARATOR

Modified Pectoralis block (PECS II) : Using ultrasound we proceed to inject 10 ml of bupivacaine 0.25% between the pectoral muscles and 10 ml under Pmm above the serratus muscle. Transversus Thoracic Plane block : 10 mL bupivacaine (0.25%) is injected between the transversus thoracic muscle and the internal intercostal muscle between the third and fourth left ribs connecting at the sternum.

Procedure: Combined Modified Pectoralis and Transversus Plane Blocks

Erector Spinae Block (E)

ACTIVE COMPARATOR

Using ultrasound an echogenic 22-G block needle is inserted in-plane in a cranial-to-caudal direction until contact is made with the T5 transverse process. A total of 30 bupivacaine 0.25% is then injected while seeing the fluid lifting the erector spinae muscle off.

Procedure: Erector Spinae block

Interventions

Combined Modified Pectoralis and Transversus Plane Blocks PROCEDURE

Modified pectoralis nerve block (Pecs II) aims to block at least the pectoral nerves, the intercostobrachial, intercostals III-IV-V-VI. This will cover dermatomes T2, T3 and T4. The probe is positioned under the lateral third of the clavicle .After locating the subclavian muscle, the axillary artery and the axillary vein we move the probe distally towards the axilla, until the pectoralis minor is identified. We start counting the ribs , from r1 under the axillary artery, we move distally and laterally until the lateral border of pectoralis minor is reached. The serratus anterior muscle which covers r2, r3, r4 is the point of entrance into the axilla. Blocking of multiple anterior branches of intercostal nerves (Th2-6) using a transversus thoracic muscle plane (TTP) block is used as an additive to pecs II to cover the internal mammary region

Also known as: PECS II and TTP

Combined PECS II and TTP blocks (PT)

Erector Spinae block PROCEDURE

The patient is placed in a sitting position and The T5 spinous process is located by palpating and counting down from the C7 spinous process. Under complete aseptic conditions a linear ultrasound probe is then placed in a transverse orientation at the level of the T5 transverse process. The tip of the transverse process is centred on the ultrasound screen and the probe is then rotated into a longitudinal orientation to produce a parasagittal view. From T1 to T5 the erector spinae, rhomboid major and trapezius muscles are visible posterior and superficial to the transverse processes.

Erector Spinae Block (E)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18: 60 years old
• ASA (American Society of Anesthesiologists) physical status I II
• Female patients scheduled for modified radical mastectomy

You may not qualify if:

• Patient refusal or inability to give informed consent
• Subjects with a medical contraindication to regional anesthesia , such as coagulopathy, local infection or an allergy to local anesthetic
• Body mass index (BMI) \>35
• Presence of psychiatric diseases
• History of chronic chest wall pain or neuropathic disorders
• Alcohol or drug abuse
• Severe chest wall deformities

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

Related Publications (1)

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.

  PMID: 29980005 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Interventions

thiamine triphosphorate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Eman A Ismail, A Lectuer

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor doctor of anaesthesia and ICU Faculty of Medicine - Assiut University

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 4, 2019
• Study Start: February 8, 2021
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)