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

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ClinicalTrials.gov Identifier: NCT03903224
Recruitment Status : Not yet recruiting
First Posted : April 4, 2019
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Bakri, Assiut University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Acute Postoperative Pain Procedure: Combined Modified Pectoralis and Transversus Plane Blocks Procedure: Erector Spinae block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Effect of Combined Modified Pectoralis and Transversus Plane Blocks Versus Erector Spinae Block on Postoperative Analgesia Following Modified Radical Mastectomy
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

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 Name: 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.




Primary Outcome Measures :
  1. The total morphine consumption postoperative (mg) [ Time Frame: The first 24 hours postoperative. ]
    Morphine consumption in mg


Secondary Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903224


Contacts
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Contact: Abdelrahman H Mohammed, Assistant Lecturer 01060989574 ext +2 abdelrahmanhm89@gmail.com
Contact: Mohamed H Bakri, Professor doctor 01066356375 ext +2 mhbakri@gmail.com

Sponsors and Collaborators
Assiut University
Publications:
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Responsible Party: Mohamed Bakri, Professor doctor of anaesthesia and ICU Faculty of Medicine - Assiut University, Assiut University
ClinicalTrials.gov Identifier: NCT03903224    
Other Study ID Numbers: Analgesia in breast surgey
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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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
Keywords provided by Mohamed Bakri, Assiut University:
Breast Cancer
Regional Anaesthesia
Morphine Consumption
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations