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

Effect of Combined Modified Pectoralis and Transversus Plane Blocks Versus Erector Spinae Block on Postoperative Analgesia Following Modified Radical Mastectomy

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Acute Postoperative Pain
• Intervention / Treatment: Procedure: Combined Modified Pectoralis and Transversus Plane Blocks; Procedure: Erector Spinae block

Detailed Description

Breast cancer is the most common malignancy in women in the United States and is second only to lung cancer as a cause of cancer death. Breast surgery is commonly performed as a part of the management of breast cancer, is associated with considerable acute postoperative pain. Ultrasound guided Regional anesthesia is recommended to be a part of multimodal analgesia in order to manage the acute post-operative pain. New techniques are proposed to give adequate control of postoperative analgesia with less opioid needs in the first day postoperative. They include pectoralis nerve modified pectoralis, and erector spinae blocks.

The investigators will compare Modified pectoralis nerve block (Pecs II) plus transversus thoracic muscle plane (TTP) block versus Erector spinae block on morphine consumption during first 24 h following modified radical mastectomy.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdelrahman H Mohammed, A Lecturer; Phone Number: +2 01060989574; Email: abdelrahmanhm89@gmail.com
• Study Contact Backup: Name: Mohamed H Bakri, Professor; Phone Number: +2 01066356375; Email: mhbakri@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Combined PECS II and TTP blocks (PT); 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; 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; Other Names: PECS II and TTP
Active Comparator: Erector Spinae Block (E); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total morphine consumption postoperative (mg)	Morphine consumption in mg	The first 24 hours postoperative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain score by Verbal numeric rating scale	Verbal numeric rating scale (VNRS) for postoperative pain monitoring using 11-point where zero equals no pain and 10 equals the worst pain imaginable.	0, 2, 4, 8, 12, 24 hours postoperatively.
Time to first request analgesia postoperative (min)	Time from postoperative period to time of first analgesic request in minutes	The first 24 hours postoperatively
Postoperative level of IL6 (interleukin 6) (pg/mL)	Preoperative baseline and postoperative levels of IL6 will be measured (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	Oxygen (mmHg) and carbon dioxide (mmHg)	Before surgery and 24 hours postoperative.

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Eman A Ismail, A Lectuer, Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Regional Anaesthesia; Morphine Consumption
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Analgesia in breast surgey

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No