Ultrasound Guided Rhomboid Intercostal Nerve Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Modified Radical Mastectomy:A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- The total analgesic requirements during the first 24 hours postoperative.
研究概览
简要总结
Despite of analgesic effect of intravenous analgesic medications at intraoperative and postoperative time , The regional anesthetic techniquehas more benefits suchbetter control of Acute pain and hence less chronic pain and decreases the need for opioids and analgesics to preserve immune function which responsible for higher rates of infection and local recurrence, even metastasis .
New regional anesthetic technique for modified radical mastectomy discovered recently called rhomboid intercostal nerve block that will compared against erector spinae plane block .
详细描述
The aim of this study is to compare the post-operative analgesic effect of ultrasound-guided rhomboid intercostal nerve block versus erector spinae plane block as regard total analgesic requirements, duration of effective analgesia,postoperative visual analog score (VAS), peri-operative hemodynamics,peri-operative complications and incidence of chronic postmastectomy pain.The technique of rhomboid intercostal nerve block:
After induction of anesthesia, the patient will be positioned in lateral decubitus with the operated side above. After sterilization of the patient's back, A linear ultrasound transducer (6-12 MHz) will place medial to the lower border of the scapula with the orientation marker directed cranially. The ultrasound landmarks, trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung will be identified. The tissue plain between the rhomboid major and intercostal muscles is identified, and a single injection is administered at the T4-5. 80mm 21-gage needle will be inserted in the plane view of the ultrasound probe at the level of T4-5. After negative aspiration of blood or air, the rhomboid intercostal plane was hydro located with 2 mL of normal saline to confirm the correct needle tip position. A single injection of 30 ml of bupivacaine 0.25% will be applied into the interfacial plane between the rhomboid major and intercostal muscles. The spread of local anesthetic solution under the rhomboid muscle will be visualized by ultrasonography.
The technique of Erector spinae plane block (ESP):
After induction of anesthesia, the patient will be positioned in lateral decubitus with the operated side above. After sterilization of the patient's back, A linear ultrasound probe willplace 3-cm lateral to the midline at the level of T5 interspinous space and transverse process and three muscles willidentify: trapezius, rhomboid major, and erector spinae. A 10-cm needle was inserted craniocaudally in-plane, to reach the transverse process. After hydrodissection of the plane with 3 mL of normal saline, 30 ml of 0.25% bupivacainewilldeposit and thus erector spinae muscle will lift off the transverse process.
Block assessment will be performed using ice cube withtemperature of 4°C at midclavicular linein post anesthesia care unit after Full recovery which be confirmed when Aldrete's score ≥9 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
- double-blind comparative study.
入排标准
- 年龄范围
- 25 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- Female patients aged between 25-65 years.
- •ASA physical status I or II.
- •Scheduled for elective unilateral modified radical mastectomy
排除标准
- •- Patient refusal.
- •Infection at the site of injection.
- •Hypersensitivity to the local anesthetic
- •Bleeding disorders.
- •Patients with cardiac, hepatic, and renal failure.
- •BMI ≥40 kg/m2
- •Patient with serum cr > 1.5
研究组 & 干预措施
rhomboid intercostal plane block
as in intervention description
干预措施: Rhomboid intercostal plane block (Drug)
Erector spinae plane block
As in intervention description
干预措施: Rhomboid intercostal plane block (Drug)
结局指标
主要结局
The total analgesic requirements during the first 24 hours postoperative.
时间窗: 0,2,4,6,8,10,12,16,20,24 hours postoperatively
All patients will receive standard postoperative analgesia (1gm paracetamol every 8 hours IV).
次要结局
- The duration of effective analgesia(0,2,4,6,8,10,12,16,20,24 hours postoperatively)
研究者
ghada fouad
associate professor of anesthesia
Mansoura University
