Breast Cancer
Conditions
Keywords
erector spinae plane block, Rhomboid Intercostal and Sub-serratus Plane Blocks, ultra sound
Brief summary
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. Erector spinae plane block is a novel para-spinal regional anesthesia technique, , promises to provide effective visceral as well as somatic analgesia after carcinoma of the breast surgeries. The ultrasound-guided rhomboid intercostal block sub-serratus plane block (RISS) is a novel analgesic technique The RISS block anesthetizes the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia
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. Erector spinae plane block is a novel para-spinal regional anesthesia technique, promises to provide effective visceral as well as somatic analgesia after carcinoma of the breast surgeries. The ultrasound-guided rhomboid intercostal block (RIB) and rhomboid intercostal block sub-serratus plane block (RISS) are two novel analgesic techniques . Additionally, the RISS block anesthetizes the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia
Interventions
PROCEDUREUltrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks
Ultrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks
PROCEDUREErector Spinae Plane Block
Erector Spinae Plane Block
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Breast cancer female patients. 2. ASA class II and III. 3. Age ≥ 18 and ≤ 60 Years. 4. Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2. 5. Type of surgery; elective breast cancer surgery (either modified radical mastectomy or conservative breast surgery) 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 |
Countries
Egypt
Contacts
CONTACTAyman Sharawy Abdelrahman Aboul Nasr, MD
CONTACTAsmaa Elsayed Khalil Elmoghazy, MD
PRINCIPAL_INVESTIGATORAyman Sharawy Abdelrahman Aboul Nasr, MD
National Cancer Institute Cairo University
Outcome results
None listed