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Breast cancer remains the most frequently diagnosed cancer and a major cause of cancer-related mortality among women worldwide. Modified radical mastectomy (MRM), a common surgical procedure for breast cancer, is associated with significant postoperative pain, which may delay recovery and contribute to the development of chronic postmastectomy pain syndrome (PMPS). To address this, regional anesthesia techniques have been increasingly incorporated into multimodal analgesia strategies to reduce opioid consumption and enhance patient outcomes. Interfascial plane blocks, in particular, offer safe and effective analgesia under ultrasound guidance. The erector spinae plane block (ESPB), first described in 2016, involves injection of local anesthetic deep to the erector spinae muscle and may spread to the paravertebral space, providing both somatic and visceral analgesia. A bilevel approach may enhance dermatomal coverage. Meanwhile, the pectoserratus plane block (PSPB), which combines PECS II and serratus anterior blocks, targets nerves of the anterior and lateral chest wall and has shown efficacy in breast surgery
Breast cancer is the most common diagnosed malignancy among females and the 5th cause of cancer-related deaths with an estimated number of 2.3 million new cases and 685,000 deaths worldwide in 2020.
Different modalities are used for management of breast cancer including surgery, radiation therapy (RT), chemotherapy (CT), endocrine (hormone) therapy (ET), and targeted therapy. Modified Radical Mastectomy (MRM) is one of the main modalities of breast cancer treatment. It accounts for 31% of all breast surgeries. It has been reported that 40% of the females complain from moderate-to-severe pain in the immediate post-operative period after breast cancer surgery.
Acute post-mastectomy pain can cause adverse impacts on the patients as delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay. It is also an important factor leading to the development of chronic post mastectomy pain syndrome (PMPS) in almost half of the patients.
Various regional anesthetic techniques have been described for postoperative pain relief after mastectomy, for example, thoracic epidural anesthesia, intercostal nerve block, paravertebral block, serratus anterior plane block, and pectoral nerve I and II blocks. All of them offer satisfactory pain relief after mastectomy.
The erector spinae plane block (ESPB), first described in 2016, involves injection of local anesthetic deep to the erector spinae muscle and may spread to the paravertebral space, providing both somatic and visceral analgesia. A bilevel approach may enhance dermatomal coverage. Meanwhile, the pectoserratus plane block (PSPB), which combines PECS II and serratus anterior blocks, targets nerves of the anterior and lateral chest wall and has shown efficacy in breast surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound guided bilevel Erector spinae plane block (ESPB) | Active Comparator | Before induction of general anesthesia, patients will be positioned in the sitting position leaning forward. The 3rd and 5th vertebral spinous processes will be first identified then the block area will be adequately sterilized and draped. The block will be done as needed using either a high frequency linear probe (6- 13 MHz) or a curved (2-5 MHz) probe of . The probe used to identify the hyperechoic transverse process shadow at approximately 1.5- 2 cm distance from the spinous process deep to the trapezius, rhomboid major, and erector spinae muscles at 3rd, 5th vertebrae. Then, an 18-gauge epidural needle will be inserted in a cephalad-to-caudad direction to reach the transverse process deep to the erector spinae muscle. Correct positioning of the needle will be confirmed through real time visualization of 2 ml saline hydro dissection at both 3rd and 5th vertebrae.20 ml of bupivacaine 0.25% will be injected at each level. |
|
| Ultrasound guided Pectoserratus Block (PSPB) | Active Comparator | For the PECS block, the patient's arm is abducted 90° and externally rotated. The ultrasound probe is positioned beneath the lateral third of the clavicle to locate the axillary vessels and subclavian artery. The probe is moved distally and laterally to the second and third rib space to identify the pectoralis major. A 20G, 100 mm echogenic needle is inserted between the pectoralis muscles; 15 mL of local anesthetic (LA) is administered in 5 cc increments. The probe is then shifted distally and laterally to the third and fourth rib space. The fascial plane between the pectoralis minor and serratus anterior muscles is identified , and 10 mL of LA is injected in 5 cc increments. For the SAPB, the probe is placed on the midaxillary line at the fifth rib level to visualize the serratus anterior and latissimus dorsi. A 22G spinal needle is inserted in-plane at a 45° angle toward the fifth rib. Saline (0.5-1 mL) is injected to open the plane, and 15 mL of 0.25% LA is administered |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound guided bilevel Erector spinae plane block (ESPB) | Procedure | Ultrasound guided bilevel Erector spinae plane block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total post-operative morphine consumption. | The total 24-hour morphine consumption will be recorded for every patient post operative. | 24 hours after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total intra-operative fentanyl consumption | the rescue analgesia will be administered intra-operative by fentanyl IV and the total fentanyl used will be recorded and compared between the groups | 2-3 hours (Surgery time) surgery |
| 1st time opioids requested post-operative. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayman Sharawy Abdelrahman Aboul Nasr, MD | Contact | 01282649008 | 0020 | ayman.sharawy@nci.cu.edu.eg |
| Yousr Farag Abdelhamid, MSc | Contact | 01095444856 | dr.yousrfarag@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ayman Sharawy Abdelrahman Aboul Nasr, MD | National Cancer Institute Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute - Cairo University | Recruiting | Cairo | 11796 | Egypt |
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| control group | No Intervention | the patients of this group received general anesthesia without regional plane block |
| Ultrasound guided Pectoserratus Block | Procedure | ultra sound guided combined Pectoral Nerve (PECS II) Block and Serratus anterior (SAPB) plane block |
|
In case of postoperative pain recorded, rescue analgesia will be provided as IV morphine (3 mg) then continuous infusion of morphine through Patient Controlled Analgesia ( PCA ) to keep the VAS scores<3. The total 24-hour morphine consumption will be recorded for every patient. |
| 24 hours after the surgery |
| Changes and stability in Mean Arterial Blood Pressure (MAP) | Change in Mean Arterial Blood Pressure (MAP) in mmHg | every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively |
| Changes and stability in Heart Rate (HR) | Change in heart rate (HR) in beat\min | every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively |
| Pain scores using Visual analogue score | Pain scores using Visual analogue score (VAS) (0 mm = no pain to 10mm = worst pain imaginable) at predetermined time intervals (1, 2, 6, 12 and 24h) postoperative. | 24 hours after the surgery |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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