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NCT Number: NCT03903224

Combined PECS II and Transversus Plane Blocks Versus Erector Spinae Block in 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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospital

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: PECS II and TTP

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.

Primary outcomes

  1. The total morphine consumption postoperative (mg)

    Time frame: The first 24 hours postoperative.

    Morphine consumption in mg

Secondary outcomes

  1. Postoperative pain score by Verbal numeric rating scale

    Time frame: 0, 2, 4, 8, 12, 24 hours postoperatively.

    Verbal numeric rating scale (VNRS) for postoperative pain monitoring using 11-point where zero equals no pain and 10 equals the worst pain imaginable.

  2. Time to first request analgesia postoperative (min)

    Time frame: The first 24 hours postoperatively

    Time from postoperative period to time of first analgesic request in minutes

  3. Postoperative level of IL6 (interleukin 6) (pg/mL)

    Time frame: Two blood samples will be withdrawn from the patient.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

    Preoperative baseline and postoperative levels of IL6 will be measured (pg/mL)

  4. Arterial blood gas: Arterial blood gas: Arterial blood gases

    Time frame: Before surgery and 24 hours postoperative.

    Oxygen (mmHg) and carbon dioxide (mmHg)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2019
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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