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

NCT ID: NCT03903224

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-08
• Study Completion Date: 2023-11-01

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.

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.

Conditions

Breast Cancer; Acute Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Combined Modified Pectoralis and Transversus Plane Blocks

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Erector Spinae block

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

PECS II and TTP

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Bakri

Professor doctor of anaesthesia and ICU Faculty of Medicine - Assiut University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman A Ismail, A Lectuer

Role: STUDY_DIRECTOR

Assiut University

Locations

Assiut University Hospital

Asyut, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 29980005 (View on PubMed)

Other Identifiers

Analgesia in breast surgey

Identifier Type: -

Identifier Source: org_study_id