A Comparative Study Between Ultrasound Guided Combined Rhomboid Intercostal and Sub- Serratus Plane Blocks and Erector Spinae Plane Block as Perioperative Analgesia in Mastectomy Surgeries in Cancer Breast Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total post-operative morphine consumption.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer female patients.
- •ASA class II and III.
- •Age ≥ 18 and ≤ 60 Years.
- •Body mass index (BMI): > 20 kg/m2 and < 35 kg/m
- •Type of surgery; elective breast cancer surgery (either modified radical mastectomy or conservative breast surgery) combined with axillary dissection.
排除标准
- •Patient refusal.
- •Age <18 years or >65 years.
- •BMI <20 kg/m2 and >35 kg/m
- •Major medical conditions.
- •Pregnancy or lactation.
研究组 & 干预措施
Ultrasound guided Rhomboid intercostal block sub-serratus plane block (RISS).
With the patient in the lateral decubitus position, a rhomboid intercostal block will be performed under ultrasound guidance using a linear probe (6-12 MHz). The transducer will be positioned medial to the scapular border to obtain an oblique sagittal view. A 17G Tuohy needle will be advanced in-plane from a superomedial to an inferolateral direction through the trapezius and rhomboid major muscles, and 10 mL of 0.25% bupivacaine will be injected at the T5-T6 level. The probe will then be moved caudally and laterally to identify the plane between the serratus anterior and external intercostal muscles for a sub-serratus block at T6-T9. Using the same skin entry point, the needle will be redirected caudolaterally, and 15 mL of 0.25% bupivacaine will be administered superficial to the intercostal muscles.
干预措施: Ultrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks (Procedure)
Ultrasound guided Erector spinae plane block (ESPB)
The patient will be placed in sitting position. The spine will be palpated from C7 downward to T5 and point will be marked to identify the spinous process. After ensuring skin asepsis, the high frequency (5-13 MHz) linear probe of ultrasound machine (Sonosite, Bothwell, USA) will be placed in a sterile sheath 3 cm lateral to the T5 spinous process. The three muscles from outward will be recognized: trapezius, rhomboidus major, and erector spinae muscle. An 18-gauge Tuohy needle will be inserted using an in-plane superior to inferior approach to place the tip into fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip was confirmed by visible fluid spread below erector spinae muscle off the bony shadow of the transverse process. A total of 20 ml of 0.5% bupivacaine will be injected through the needle.
干预措施: Erector Spinae Plane Block (Procedure)
结局指标
主要结局
Total post-operative morphine consumption.
时间窗: 24 hours after the surgery
The total 24-hour morphine consumption will be recorded for every patient post operative.
次要结局
- Total intra-operative fentanyl consumption(2-3 hours (Surgery time) surgery)
- 1st time opioids requested post-operative.(24 hours after the surgery)
- 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)
- 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)
研究者
Ayman Sharawy Abdel Rahman Aboul Nasr
Principal investigator
National Cancer Institute, Egypt