Breast Cancer
Conditions
Keywords
erector spinae plane block, pectoserratus block, ultrasound
Brief summary
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
Detailed description
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
Interventions
PROCEDUREUltrasound guided bilevel Erector spinae plane block (ESPB)
Ultrasound guided bilevel Erector spinae plane block
PROCEDUREUltrasound guided Pectoserratus Block
ultra sound guided combined Pectoral Nerve (PECS II) Block and Serratus anterior (SAPB) plane block
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Breast cancer female patients. 2. ASA class II and III. 3. Age ≥ 18 and ≤ 65 Years. 4. Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2. 5. Type of surgery; elective breast cancer surgery modified radical mastectomy combined with axillary dissection.
Exclusion criteria
1. Patient refusal. 2. Age \<18 years or \>65 years. 3. BMI \<20 kg/m2 and \>35 kg/m2. 4. Major medical conditions. 5. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total post-operative morphine consumption. | 24 hours after the surgery | The total 24-hour morphine consumption will be recorded for every patient post operative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total intra-operative fentanyl consumption | 2-3 hours (Surgery time) surgery | the rescue analgesia will be administered intra-operative by fentanyl IV and the total fentanyl used will be recorded and compared between the groups |
| 1st time opioids requested post-operative. | 24 hours after the surgery | 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. |
| Changes and stability in Mean Arterial Blood Pressure (MAP) | every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively | Change in Mean Arterial Blood Pressure (MAP) in mmHg |
| Changes and stability in Heart Rate (HR) | every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively | Change in heart rate (HR) in beat\\min |
| Pain scores using Visual analogue score | 24 hours after the surgery | 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. |
Countries
Egypt
Contacts
CONTACTAyman Sharawy Abdelrahman Aboul Nasr, MD
CONTACTYousr Farag Abdelhamid, MSc
STUDY_DIRECTORAyman Sharawy Abdelrahman Aboul Nasr, MD
National Cancer Institute Cairo University
Outcome results
None listed