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
|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|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|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|
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.
- The total morphine consumption postoperative (mg) [ Time Frame: The first 24 hours postoperative. ]Morphine consumption in mg
- 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.
- 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
- 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)
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903224
|Contact: Abdelrahman H Mohammed, Assistant Lecturer||01060989574 ext +firstname.lastname@example.org|
|Contact: Mohamed H Bakri, Professor doctor||01066356375 ext +email@example.com|